How We go the Extra Mile to Support Your Clinical Trial Needs: 50 Sponsor Reviews You Must Read

Navitas Life Sciences remains committed to transforming clinical trials using technology led innovations, data analytics and the vast experience of experts. To mark our 50th blog, we have put together a collection of sponsor reviews of the stellar work that we provided them with, rethinking strategies and shifting priorities, even during the throes of the COVID-19 pandemic.

Our fundamental pursuit has been to bring lifesaving drugs to the market sooner, supporting multiple sponsors in running cost and time efficient clinical trials.

Clinical Research

With over 30 years of experience in conducting clinical trials, we understand your key challenges and have established systems to run a successful trial. Right from phase I to phase IV, we support your organization from startup to closure, and beyond, with our regulatory insights and quality approach.

IDMP

1) “Excellent feedback received on Medical Data Review performed on a phase IV oncology trial. The trial required sharp review of safety and efficacy data including vitals, physical examination, hematology, biochemistry, urinalysis, ECG, immunogenicity, Echo, imaging, bone scan, AE / SAEs. The causality assessment of the events caused due to underlying malignancy versus those caused by study drug required detailed analyses at the individual level as well as collated data review to identify any new safety signal” - Oncology Study for a Global Pharma

2) “Excellent feedback received on a high complex Clinical Study Report (CSR) for a Phase III covid-19 study. The study had multiple complex and composite endpoints considering that the disease was behaving in a highly unpredictable manner and natural history of disease was not well known at the time of study conduct. The in-depth analyses were required to identify the treatment effects, multiple post hoc analyses to identify the right timing of drug treatment and multiple subgroup analyses” COVID-19 Study for a global Pharma

3) “Appreciation and excellent feedback was received directly from all the regulatory authorities involved- USFDA and CDSCO on the study design. The trial was a complex adaptive phase II/III global protocol with innovative design for critically ill covid-19 patients to be conducted in USA and India. The study drug was a novel therapeutic with multimodal approach and the study design was quintessential in ensuring that while the safety is well established, but at the same time adaptation in study protocol is feasible based on interim results” COVID-19 Study for a U.S. Based Pharma

4) “Excellent feedback on the phase III protocol on an Investigational agent for colonoscopy. Considering a limited budget study from a small size company, the protocol was developed with a pragmatic approach in line with customer’s requirements. The study design ensured that the scientific requirements are met within the finite resources. The study methodology including the study visits, transferring the data to assessor, interim analysis etc all were balanced to achieve operational feasibility while ensuring the scientific validity” Study conducted for Global Pharma

5) “Appreciation received from the client on the phase II protocol on an Investigational agent for glaucoma. The synopsis developed by the client was critically reviewed by medical lead and accordingly important changes were suggested in the type of study population, comparator agent and interim analysis. Also, considering the SEC meeting requirements, the turnaround time was extremely fast and quick collaboration was done with KOLs to ensure that highly efficient protocol can be developed even within the very short timelines.” Study conducted for Global Pharma on Glaucoma

6) “We are very happy with the work done to date on our project” We received appreciation from a global pharma in a mail with a high score on client satisfaction for support that we had extended for statistical analysis section of the Phase III non-inferiority. However, Navitas went the EXTRA MILE and proactively supported the client by providing guidance on the sample size, Unblinding methodology, handling dropout(s), Replacement of subjects, baseline CBC balancing, DSMB, safety stopping rules. This led to fast tracked planning and implementation of the project from Sponsor, with appreciation from the sponsor.

7) “Fantastic news. Hearty congratulations to the entire team.” A global pharma was happy with the proactive fast tracking of recruitment from Navitas to ensure conformance, even during COVID-19 mediated delays due to lockdowns, lower patient foot fall, etc. This led to Navitas completing the expected recruitment two months ahead of projection during COVID-19 Pandemic. This led to ‘Customer Delight’ and the Client appreciation.

Our clients include US Federal Government institutes and non-profits

8) The Centers for Disease Control and Prevention (CDC):

For the past 7 years, Navitas Life Sciences has supported the CDC on their Pre- and Post-Influenza vaccination Sera collection Study. The aim of the study is to determine if the current seasonal influenza vaccine induces antibodies effective in inhibiting currently circulating influenza virus strains. The ability of antibodies in post-influenza vaccine serum samples to neutralize currently circulating influenza viruses is a measure of how effective the current vaccine will be at inducing protective antibodies against circulating influenza viruses.

The study enrolls subjects in every age category, from 6 months of age through elderly. Navitas Life Sciences has worked with the same site network each year to quickly enroll all subjects and deliver the required pre- and post-vaccination serum samples to the CDC. The study requires a very quick start up and enrollment in order to ship the samples to the CDC according to the predetermined timeline.

Most years, the entire study enrollment (400-500 subjects across all age cohorts) enrolls in approximately 2 weeks from site activation. Due to the pandemic, enrollment has been slower, particularly in the youngest cohort. Navitas Life Sciences worked with the sites to develop mitigation strategies for getting the babies enrolled and serum samples delivered to the CDC.

9)Drug and medical device clinical trials help to ensure that every new medication and device is safe and effective. From everyday household items such as oral thermometers and blood pressure monitors to complex implantables, such as deep-brain stimulators and cardiovascular stents, medical devices play a critical role in the lives and health of millions of people worldwide. Consequently, patients and the public rely on regulatory agencies, institutional review boards, and clinical research organizations to ensure that legally marketed medical devices have been shown to be safe and effective.

Navitas Life Sciences has been on the forefront of cutting-edge device research for federal agencies as well as commercial Sponsors for many years. Through our work with the Walter Reed National Military Medical Center, a device that would otherwise not be available to Veterans in the US is being evaluated for feasibility as an alternative to traditional socket-based prosthetics.

In the private sector our clients have returned for our support on multiple studies, seeking out our dedicated teams for creative problem solving. This approach to thinking outside the box has garnered such praise as “Your plan sounds great and thanks again for all the amazing work from the entire Navitas Life Sciences team!” and “way to be proactive - go Navitas Life Sciences team!!!!”

10) Common Data Elements (CDEs) and Standard Development Program.

The clinical data standards space continues to evolve rapidly. Research suggests that implementing therapeutic and disease specific CDEs and standards can save study teams up to 70-90% of time and resources during the start-up stage and ~ 75% of non-patient participation time during study conduct and analysis stages. Various agencies and organizations, including the NIH and FDA, are attempting to harmonize data standardization efforts and develop a computing infrastructure to enable metadata and data analysis.

Navitas Life Sciences Team’s systematic approach to selecting and assembling master set of relevant data elements is based on the experience and expertise necessary to achieve the right level of semantic interoperability for meaningful data integration. Our collective experience includes support of the strategic development of structured standard data elements, definitions, and related metadata within the framework of defined best practices. It helps achieve quality combined with efficiency, develop metadata driven IT systems, and promote data sharing and efficient analysis. Navitas Life Sciences has implemented its own library of eCRFs that contains de-identified forms based on CDISC SDTM (Study Data Tabulation Model) and CDASH (Clinical Data Acquisition Standards Harmonization) models from previous clinical trials supported by our team, and actively participates in the development of the CDISC data standards and terminology for a variety of therapeutic areas to support FDA study data standard submission.

Collectively, our team has contributed to the development of over 13,400 standardized CDEs and their supporting documentation (including over 600 CRFs and assessments), in addition to contributing to over 51,000 CDEs in our role as central CDE curation and harmonization team, to support the entire NCI Cancer Data Standards Repository (caDSR) CDEs.

Navitas Life Sciences has continuously supported the development and harmonization of metadata for the National Cancer Institute (NCI) CDE Harmonization project. Engaging large networks in standards development provides significant value as it ensures the development of harmonized and noncompetitive standards that will lead to the adoption of a common information model and common data model. Navitas Life Sciences and our teaming partner support NCI align NCI CDEs with CDISC CDASH and SDTM through collaboration with CDISC. In addition, we worked with the National Institute of Neurological Disorders and Stroke (NINDS) to map data from completed NINDS and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) clinical trials to CDEs. We have supported standardized data collection, metadata content development and storage, and data governance to improve overall data accessibility, consistency and completeness for many commercial clients as well.

Kudos from our NCI PO: “To my dedicated Metadata Content Team members, Ladies, I have worked with some mighty fine folks over the years - but this team, this team is THEE BEST!!! Your expertise, professionalism and collegiality even in the face of dismissive and sometimes overly aggressive interactions is awe inspiring. Your constant attention to finding the answer and finding the best solution for all of our community is admirable. Even when the problem seems insurmountable, you all are trying to find a path forward. NIH, NCI, CBIIT appreciate you and your service. “

11) DSMB Support

Navitas Life Sciences has provided support for the management and support of Data Safety Monitoring Boards to government and private business sectors for many years. In that time, NCR has developed and streamlined processes to ensure all efforts in relation to DSMB’s exceeds the client’s expectations.

Typical DSMB responsibilities are placed on the Investigator(s) or DSMB members. Our services allow Investigators and DSMB members to focus on the task at hand while we coordinate the logistics of routine DSMB meetings, including pre- and post-meeting support. Responsibilities that NCR takes on prior to the meeting include scheduling assistance, agenda creation, dissemination of materials, and meeting reminders. During the meeting, we provide the meeting platform, facilitates the meeting, shares meeting materials, provides guidance to attendees, and provides a summary to the client’s expectations. Post-meeting responsibilities include drafting and disseminating meeting summaries and recommendations to attendees for review and finalization. For some clients, we review the DSMB’s recommendations in real-time to expedite the review process. For the lifetime of the DSMB, NCR facilitates communication between the investigator(s) and the DSMB, in a timely fashion, to maintain independence. In addition, we coordinate insurance coverage for DSMB members.

Navitas Life Sciences consistently receives appreciation from DSMB members and Investigators at meetings and via emails for the routine assistance we provide. Many monitoring board members are used to conducting meetings themselves while taking notes; our services allow the DSMB members to focus on the science of the studies, while we handle the details of coordination. Clients (to include investigators, DSMB members, sponsors, and the government) routinely express gratitude for the freedom to enjoy their role and participate in exciting scientific advances.

12) Navitas Life Sciences at the Forefront with Big Data Management and Registry Programs

As utilization of electronic medical records become more widespread in clinical care of patients, researchers and sponsors find there are new opportunities to access comprehensive data from tens of thousands of patients from a single network. This type of data has huge potential for the way clinical research is managed and outcomes are measured. One way to capture electronic medical data for use in clinical research is through a registry study. This type of research captures patient information using electronic databases, which can be used to provide powerful insight to population-level data related to disease progression, lifestyle patterns, medication use, and clinical outcomes.

Navitas Life Sciences is at the forefront of this big data trend in electronic medical record utilization and collection of electronic patient-reported outcomes by offering expertise in registry database development, data management, and statistical analyses. Navitas Life Sciences facilitates registry development by focusing on these key areas:

Database Development and Utilization of eSolutions:

Working closely with clients, Navitas Life Sciences ensures that databases are built to capture the necessary information needed to determine required endpoints. It’s important to clarify whether data will be collected directly from patients using tablets or wearable devices or managed by clinical or research staff using electronic medical records. Jessica Figueroa, MS, Associate Project Manager at Navitas Life Sciences notes:

“Current technology allows for seemingly infinite possibilities when it comes to data collection for registry studies. Clients should provide guidance on their outcomes of interest and the resources that are available. It’s up to Navitas Life Sciences to ask additional questions about priority areas of interest, the availability of validated questionnaires or licensed testing, and the involvement of clinical providers or caregivers in addition to patients in data collection. Together, we work closely with clients to build a database that achieves their registry goals while being functional for our team.”

Navitas Life Sciences evaluates the capabilities of eSolutions allowing for remote informed consent and virtual patient visits and makes recommendations to the client regarding what would work best given the patient population and data sources. Rigorous beta testing of the final product is implemented to ensure burden is minimized for patients or others who are responsible for data entry. The result is a database capable of managing data from potentially thousands of patients, allowing clients access to dataset rich with patient-centered information

Outcome-Driven processes for multiple stakeholders

When building a prospective data system for a registry study, Navitas Life Sciences keeps in mind that there can be multiple stakeholders involved with registry development, in addition to the client. Each stakeholder’s priorities must be considered during the registry development process. Ms. Figueroa describes a unique, prospective data system currently in the works:

“I am currently working on a registry study that will allow for patients to view their health information and will provide insight to changes in various metrics over time. This allows patients to learn more about themselves and allows access to data they might not otherwise be able to easily obtain. Researchers benefit from this data as more patients participate and continue to be followed over time. And these datasets can produce valuable population-level trends, which can inform effectiveness of current standard of care practices.”

Patient-Centered Methods of Data Collection:

In order to ensure maximum participation in registry studies, Navitas Life Sciences works closely with clients to develop data collection procedures that are patient-centered, by catering to the specific populations that are being targeted for the registry. An example of a patient-centered practice is use of eConsent, which allows individuals to consent to research participation without being on site at a research location. Patient-centered methods of data collection include hyperlinks allowing remote data collection or the use of tablets in a clinic setting. Each method presents opportunities for increased participation, but can present challenges to the data and clinical operations team including issues with privacy and confidentiality, ensuring understanding on the part of the patient, and equal access for some vulnerable populations.

By developing proper database systems, providing appropriate eSolutions, focusing on patient-centered approaches to data collection, and prioritizing outcome-driven measures, Navitas Life Sciences looks to position itself ahead of the curve in big data of large electronic medical records and self-reported outcomes for prospective and retrospective data.

Generics Development

Bioavailability (BA) and Bioequivalence (BE) studies are carried out for developing a new formulation or for marketing a generic drug. In order to market a generic drug, BABE studies are required for approval from health authorities like US FDA. The drug that is being tested is studied against a well- known and commercially available drug, at same concentrations and under conditions that are similar. Companies file their Abbreviated New Drug Application (ANDA) according to 505 (j) or 505b (2) to the US FDA for marketing authorization in USA. Selection of the right clinical research organization is vital for a successful market launch.

IDMP

13) “We appreciate the continuous support provided by Navitas Life Sciences in effectively planning the respiratory Pk studies, executing clinical phase flawlessly and ensuring study timelines are met. We also appreciate the inputs provided on regulatory requirements for conducting PK studies. Special thanks to Navitas Life Sciences for seamless coordination and providing quick solutions for resolving unexpected problems during planning & execution of PK studies. We look forward for your continuous support for ongoing and future planned PK studies.”Global leader in Generic Pharmaceuticals and Biosimilars.

14) “Global innovator Pharma company appreciated the efforts Navitas Life Sciences have taken for the execution of Budesonide Multimatrix Tablets during the challenging condition of COVID-19 pandemic.

Conduct of study during the Covid Pandemic with strict adherence to the CAB and Work Instructions. Transportation and commuting of subject during this challenging time where in Govt announces restriction with short notice. Long stay of subjects needs willing subjects who adhere to stay inhouse for entire study adding to recruitment challenges. Probability of subjects or the study personnel being getting infected and subsequent handling as per the prevailing norms”.Global Innovator Pharma Company.

15) “We value your support and enjoy the professionalism Navitas Life Sciences showcased. We would like to thank all the Clinical, bioanalytical, report writing and other operational team who supported us to complete these studies on time. It is worth to mention here that the commitment shown by Navitas Life Sciences team which transformed the promise into a reality. We thank you from bottom of our heart for the extended support kindly pass our gratitude to all the members.”Leading Indian Pharmaceutical company.

16) “Now that the clinical portion of this PK/PD study is completed I wanted to express my appreciation for the hard work and effective execution of the clinical team. Thank you for ensuring a smooth and stress-free (for me at least!) dosing period for this PK/PD.”

Thank you very much. We really appreciate all the work put in by Navitas. This has been a very successful partnership and I hope we are able to work together again in the future.”Multi-National Pharmaceuticals Company.

17) “I thank you for your outstanding support & cooperation ensuring the completion of our Ph-I study. Swift communication & commendable operational planning has been the key to reach to successful completion.”Leading Indian Biotech Firm.

18) Thank you very much for getting the report done on time. We really appreciate all efforts!!”Leading South Korean Pharmaceutical company.

Data Sciences

A functional service provider for your biometric needs. Navitas Life Sciences builds bespoke teams of highly skilled Statistical Programmers (both US-based and Global Programmers), Biostatisticians, and Data Managers.

19) “We received notification today from Regulatory that the Supplemental Biologics License Application (sBLA) has received FDA APPROVAL today. I would like to extend my congratulations and thank you to the Navitas programming team who worked tirelessly to support this! This is fantastic news! A huge accomplishment for the team!” Director, Statistical Programming- Top 10 US Pharmaceutical Company

20) “The studies have been finalized and I wanted to send a note of appreciation to the US team. The team did a tremendous job working through a number of milestones over the past 16 months. Through Navitas Life Sciences’ excellent leadership, the final submission deliverables were finalized. A special thank you to the team for doing a fantastic job critically reviewing data issues during the development of the SDTM and ADaM. The source data was especially challenging for these trials, but the team prevailed!!! Thank you.” Associate Director, Biostatistics Programming- Top 50 US Pharmaceutical Company

21) “I would like to take this opportunity to thank each one of you for making this deliverable in record time with quality. As you all know the importance of this critical pivotal study for needed patients and our company, you all have performed at your best with a lot of composure, and consistently excelled at all levels to reach this far. Your dedication and perseverance are top-notch. I am very happy with the team’s skillset, dynamics, hard work, flexibility, and leadership. I have received consistent positive feedback from our stakeholders. Keep up the good work!! Thanks again.” Director, Statistical Programming- Top 50 US Pharmaceutical Company

22) “We want to thank all of you for your commitment and hard work to meet the timelines and create high-quality work. Thank you for all the long hours, weekends, and dedication to see these results being delivered. A big thank you to the leadership and all the programmers from other groups who helped us when we were at a crunch time. THANK YOU!” Associate Director, Statistical Programming- Top 50 US Pharmaceutical Company

23) “Today we ran the final CSR programming deliverables in Production. This is a big accomplishment and I want to thank each and every one of you for a job well done. We had quite a few challenges along the way (data was quite problematic) but the team always persevered and did a terrific job getting the programming deliverables prepared. Thank you all.” Associate Director, Statistical Programming- Top 50 US Pharmaceutical Company

24) “I want to thank you and your team for pulling off this urgent delivery of IMC outputs at such short notice. I am aware of the last-minute issues that you came across during the delivery and worked late hours to be able to deliver all outputs on time. This is a really appreciable effort, especially from your end. Thanks a ton for all the hard work. Cheers and thanks!!” Statistical Programmer Analyst- Top 10 US Biotechnology Corporation

25) “First, I want to commend and recognize the quality of the work and the flexibility you all have demonstrated. Thank you all very much. Please extend my sincere gratitude back to everyone in India. We’re off to a great start”. Executive Director, Clinical Data Sciences- US Biotechnology Company

Pharmacovigilance and Regulatory Affairs

Strategic Partnerships to optimize your regulatory processes, drive first-time-right submissions, and enable life cycle management. With a rich legacy of experience and expertise, we serve as trusted advisors and provide tailored solutions grounded in industry best practices.

IDMP

26) Navitas Regulatory Publishing team have been supporting Covid-19 submissions since Nov 2020. Dedicated team in a secured space with a dedicated publishing POC to handle blinded studies for COVID-19 IND’s. Navitas team started supporting US/CA/LATAM initial application submissions initially and expanded the support for global markets.

  • Robust publishing workload management model established during APAC time zone. Seamless collaboration was evidenced through SWAT team set up.
  • COVID-19 submissions war room in TEAMS was set up for workload co-ordination of COVID submissions between client hubs and Navitas team to ensure faster delivery and right first-time submissions
  • Faster communication was facilitated through TEAMS, with issue resolutions with client stakeholders for faster marketing approvals
  • Quick TAT ensured by following the sun model support through effective collaboration between Navitas India and Colombia team

“Wanted to take the opportunity to thank the team for their contributions and teamwork! It is truly an achievement and we appreciate the strategic partnership with Navitas and look forward to our continued success as we work together on upcoming important submissions”

27) Navitas Regulatory Publishing team collaborated with a global pharma to ascertain the dispatched submissions being archived in DMS system and tracked in client Product tracing tool for dispatch status. The scope of the work initially started with eCTD submissions and a dedicated team had been set up and completed 622 applications in Upjohn portfolio of client drug products.

  • Team had to assess 25 products, 621 Applications for US , CA, EU markets within 1 month timeline.
  • Weekly targets were set, and accomplished the quicker milestone through close collaboration with client stakeholders
  • Submission level gap assessment & tracking for each of the application was done through comparing archiving system , file share and product tracking tool well within the timeline and received appreciation for the great work during monthly operational call with leadership team

“We appreciated Navitas team support, We are well on our way in meeting our goal!. THANK YOU for all your efforts in pushing this forward”- Gap analysis / Assessment of archived submissions

28) Client requested Clinical study reports (CSR) document level Submission publishing support. Navitas Regulatory Publishing Team started Supporting CSR submission from Oct 2019. Initially it started with a pilot phase of 3 months and moved to business as usual (BAU) from Jan 2020. The team delivered high quality deliverables and had a good rapport, flexibility & seamless collaboration with the client team.

  • Evidencing seamless collaboration , worked with client team to understand the requirements quickly during pilot phase and team leveraged domain centric capability by providing attention to detail and fulfilled all complex and minute hyperlinking requirements in each and every CSR component of the dossier to achieve quick TAT and right first time deliverables
  • Client appreciated our quick turnaround during the pilot Phase and our quick ramp up model through train the trainer model
  • Implemented unit costing model from Time and material after 6 months of project initiation
  • Showcased 12% Effort efficiency to client in 2021 for all Phases of CSR reports when compared with 2020 average efforts

“The CSR has successfully been published to GDMS. And no findings for all the documents by my final QC!!! Thank you both so much for your support, with such a high quality and efficiency!!! Your work really helped the team meet the timeline, and this is truly appreciated”

29) As a continuation of Clinical study report submission, a global pharma requested additional publishing support to handle Special Population Modeling Analysis Report (PMAR) for CSR project. The client expected quick turnaround deliverables amidst complexity.

  • Navitas team initiated train the trainer model approach during project transition and achieved the milestone quickly. Pilot Phase started in April’21 and became BAU from July’21
  • Quick TAT for all requests were achieved before the expected time frame due to efficiency increase.
  • Demonstrated effort efficiency and implemented unit pricing during the BAU Phase
  • Delivery is made with 100% right first time submissions

“We appreciated Navitas team for High quality in PMAR submissions with no quality finding recorded up to date.”

30) A global pharma requested IMPD dossier publishing support. Navitas Regulatory Publishing Team started Supporting submission from Oct 2019. Kicked started as Pilot in India for 1 month and ramped up to BAU from 2nd month of support. The team delivered high quality deliverables and had a good rapport, flexibility & seamless collaboration with client team

  • CMC IMPD Team in Navitas initiated train the trainer model approach during project transition and achieved the milestone quickly within 2 months.
  • Team need to pay attention to detail and fulfilled all complex and minute hyperlinking requirements in each and every CMC component of the dossier
  • There is single no quality issue has been recorded for past 2 years.
  • Implemented unit costing model from time and material (T&M) after 6 months of project initiation
  • Showcased 22% Effort efficiency to client in 2021 when compared with 2020 average efforts

“At the end of 2020 and the beginning of 2021, we’d like to say big THANK YOU to you for the great collaboration we had on CMC IMPD publishing during the past year. You played an important role and we’re delighted to witness the efficiency improvement in Navitas team. Your sense of responsibility, high quality and fast turnaround which ensured the timely delivery of CMC IMPD dossier and further contributed to the clinical trial application. More importantly, we sincerely appreciate your great support during busy COVID-19 submission period. Looking forward to the collaboration in 2021!” - We successfully implemented Unit Pricing Model for IMPD publishing support

31) Navitas team was requested submission publishing support for Prevnar 20 – Day 120 response. The submission has very stringent timelines and need to meet and deliver with quick targets. It is an extremely important complex HA response submission with very aggressive timeline to meet submission deadline, Sep 10, 2021.

  • The Navitas team followed SWAT model strategy and the sun model to achieve this milestone though intense planning and support extended across 2 shifts in Navitas.
  • TEAMS channel was effectively utilized to fix any changes immediately and avoided waiting time
  • Team worked based on daily targets with high level quality and had achieved the milestone within 10 days and saved 5 days for client stakeholder review

“Submission would not move so smoothly without your great effort for delivering a such efficient and high-quality work! Sincerely appreciated!” We successfully delivered critical submission on-time

32) Client awarded a special project to Navitas team based on earlier experience with Navitas to handle complex filings. Client reached for supporting a drug’s 20 Initial NDA submission filings for US market. The submissions had more than 3000 patient client record forms (CRFs), 48 clinical studies and very large CMC package accounted with 3000 plus documents to handle. Due to complexity and submission size, client split the submissions into 2 roll outs for Health Authority.

  • A team of senior publishers with a dedicated SME as a POC was allocated to handle the submission and TEAMS channel were effectively utilized for submission transactions
  • Only dedicated senior Folks had been deployed to handle complex CSR studies in the dossier and had 3 level of quality gates to ensure error free deliverables
  • Daily target was fixed and agreed with client POC and the team proactively scheduled the activities on a rolling model
  • Navitas SME/ Point of Contact (POC) liaised with Client POC to ensure requirements were met on a daily basis to achieve the milestone

“A very special Thank You Navitas and to all of the Publishers who supported this large and complex submission. This was the largest CMC package ever submitted in a single filing and the Publishing team was outstanding in following a complex linking strategy and working through the large volume with amazing efficiency”

33) Client reached out on 01st Aug submission publishing support for a drug’s Day 120 response to EMA. With stringent timeline, team delivered with right first-time submission within 15 days’ time frame and submission deadline was Aug 16th, 2021.

  • A dedicated POC from Navitas was allocated to coordinate with special requirement and mainly focused on quality and timeline
  • Submission was very proactively handled in escalating the handoff issues. The issue resolutions were quickly transacted though TEAMS channel, with email communications to help stakeholders & client team to get it completed within the timeline.
  • Navitas POC Coordinated with client submission lead on daily basis for updating the status and to provide complete transparency

“Excellent job!!! Thanks so much for your strong support with high quality and efficient. Really impressed”

34) Navitas Colombia team supports products license support by coordinating with country supplier for getting certificates and samples required as a component in a dossier. They also are required to ensure that legal / local country requirements were fulfilled through legalization team, once certificates had been sourced.

  • Navitas had a good rapport and collaboration with country supplier for getting all the three required Letter of authorization (LOA) documents for the health authority submissions
  • We exhibited domain centricity values by ensuring that the requested letter of authorization was accurate and as per stakeholder expectation. Guaranteed right first time LOA’s were delivered and showcased excellence in the deliverables
  • We went the extra mile by supporting quicker delivery, which was within less than a week than the targeted schedule of 30 days through effective communication, planning& tracking & collaboration with country stakeholders,

“You make me so proud. You displayed “role model” behavior and provide fantastic customer service. Thank you for representing our GRRS team with excellence. Congratulations!”

35) Navitas Regulatory Publishing team deployed centralized data entry support resources for client Mergers and acquisitions transfer projects since May 2020 in India and Colombia. The team delivered high quality deliverables and had a good rapport, flexibility & seamless collaboration with the client team.

  • High quality output with no single instance of deviation in delivery timeline
  • Focused right first time with higher than 98% compliance
  • Maintained KPI consistency well within the agreed limit
  • Highly proactive in issue resolutions with client stakeholders
  • Took ownership in providing knowledge transfer to client on the process changes and updates. Have proven domain centricity and continued collaboration.

“Dearest Navitas, On behalf of Global Shared Services team, I would like to appreciate for your knowledge sharing session during transition of SCC General Correspondence Notifications from regional cluster to Shared Services team. Your efforts on this project will surely help us a lot while processing live General Correspondence forms by Shared Services team.

Looking forward for your continued cross functional support and collaboration as usual as always! Thank you for living the value of EXCELLENCE! - Showcased high expertise in training client stakeholders”

36) A large pharma requested ANDA NCE-1 preparation with pre-defined submission window of April 11th, 2021. Navitas team has initiated preparation and submission in October 2020.

  • Regulatory Strategy provided in all stages of ANDA Filing (batch manufacturing, data generate and Patent amendment Submission)
  • Technical authoring - CMC documents, Labeling and Artwork
  • US agent services
  • We have worked with multiple stakeholders like API & DP manufacturer, CRO, Applicant and Analytical labs and ensured the submission delivered within committed timeframe.

A large Pharma highly appreciated Navitas team support for their ANDA awarded with first to file (FTF) status (Listed in Paragraph IV Patent Certifications (PPIV) in FDA database).

Industry Networks

Our industry leading networks can help raise the profile of both your company and your team. Join your peers and be part of an independent sounding board where you can test and validate the latest thinking, and uncover industry insight to develop compelling, yet pragmatic strategies to provide business value and meet the needs of patients, payers, and prescribers.

37) “Our experience with Navitas Networks confirms the membership provides a unique opportunity to uncover strategic and operational insights, which we then apply across our Global PV business, it is highly valuable in shaping our future PV direction” - Head of PV operations – Top 5 Global Pharma company

38) “The forum meetings and the gathering of peers is always a fantastic opportunity to network and gain insight, excellent leadership through the sessions – thank you” - Global Head of pharmacovigilance, Top 10 Global Pharma Company

39) “This is really EXCELLENT data, Thank you so much! I believe this is the kind of insight that demonstrates the value of the PVNet benchmark.” - Head of Strategic Business Planning & Execution, Top 10 global Pharma Company

40) “The May meeting was certainly one of the best regulatory events I've attended …… we will be happy to participate in any other events you host” - Top 10 global Pharma Company

pvconnect Attendees

41) Thank you so much for today’s session – relevant, interesting and thought provoking topics. Fantastic presentations as well! The four hours truly flew by between presentations/surveys/breakout sessions.

42) Thank you so much for the opportunity! The questions and feedback were great and gave me lots of ideas to consider. The rest of the meeting was very interesting and has great presentations. I am always impressed by your ability to manage the meeting, share your energy, ask great questions and make it engaging all at the same time! It is a pleasure to work with you.

pvnet Attendees

43) That was an excellent forum, thank you!

44) Great topics and great presentation, thanks

rimnet Attendees

45) Great meeting everyone, really looking forward to sharing experiences and moving RIM forward together.

46) I was at one of the very 1st rimnet meetings in NYC years ago. I’m glad to see how the forum has progressed and so thrilled to be a part of these discussions.

labelconnect Attendees

47) Great session – time was short as is appropriate for virtual – break out was valuable but wish we had more time

48) Excellent job

labelnet Attendees

49) First time at labelnet for me. Great experience, thank you!

50) I was fortunate to attend the labelnet Spring Forum Session – Workforce and Target Labeling and thought it was extremely valuable

We would like to thank all our sponsors for choosing us as their trusted partner and for engaging with us continuously in their path towards building a healthier community.

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