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Connect with Navitas Life Sciences’ Experts at these Events in 2022
Navitas Life Sciences remains committed to transforming clinical trials using technology led innovations, data analytics and the vast experience of experts. Here are a few events and webinars where you can reach out to our experts and gain from their insights
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.
“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
Be the Expert 2022
Date: 07 – 09 June, 2022 Venue: Virtual
We are pleased that Navitas Life Sciences Labeling Networks Lead, Tris Nockles, will be presenting at Amplexor Life Sciences’ virtual conference, Be the Expert. The event will bring together leading subject matter experts and industry professionals from around the globe to discuss and exchange strategies to combat challenges confronting the life sciences industry.
With digital labeling already widely available across the globe Tris’ session titled The Future of Labeling – A Digital Reality? will explore the focus needed to ensure that both patients and healthcare professionals have access to the most up-to-date label.
PV and Regulatory Network Forums
Date: June – September, 2022 Venue: Virtual
Established in 2001, our networks community is the place to discuss trends, insights, and future solutions. The philosophy behind each network is to provide a platform for industry peers to learn and share from one another in an open environment, deliver benchmark information to compare and measure operational and organizational performance.
Regular forums have been structured to derive best practices that help develop innovative future solutions to tackle shared challenges, They provide a great platform to discuss key issues facing organizations with ‘hot topics’ addressed by action teams, and provide access to the latest industry insights through webcasts, think tanks, and community exchange, working sessions to surface industry trends and explore future strategies to boost performance and success.
Data Sciences
A functional service provider for your biometric needs, Navitas Data Sciences builds bespoke teams of highly skilled Statistical Programmers (both US-based and Global Programmers), Biostatisticians, and Data Managers.
“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
PHUSE India Summer Single Day Event
Date: 11 June, 2022 Venue: Virtual
We are pleased that Navitas Data Sciences’ Shrishaila Patil will be producing his second PHUSE India Single Day Event (SDE) of the year as the India SDE Lead for 2022. We are also delighted to share that Navitas Data Sciences are committed as a PHUSE Media Sponsor for 2022. This event will be taking place virtually on Saturday 11 June. Chaired by representatives from Bayer and IQVIA, the event will look to explore Virtual Trial Design, Hybrid Trials, and Digital Data Collection Methodologies including Mobile Technology, Wearables, ePRO, and eCPA.
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.
SCDM Annual Conference
SCDM Annual Conference is the world’s leading Clinical Data Management Conference and provides a platform to share meeting of minds, practical insights, workshops, big idea presentations and, of course, exciting debate formats to encourage the sharing of the latest insights and learnings for greatest impact, between industry experts. The conference will feature over 800 plus participants and will include more than 80 sessions and 210 speakers from 37 countries across the globe. The SCDM Annual Conference exists to drive progress across the world and to support the evolution from Clinical Data Management toward Clinical Data Science.
Date: 11-14, September 2022 Venue: San Antonio, Texas
Meet Sowmya Kaur, Executive Vice President, Navitas Clinical Research (a part of Navitas Life Sciences) and other experts to gain insights about managing efficient clinical trials.
“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
Navitas Life Sciences Supports Big Data Management and Registry Programs
As utilization of electronic medical records become more widespread in clinical care of patients, researchers and sponsors find that 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.”
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.
Navitas Clinical Research and OpenClinica proudly present a webinar on
“Digital registry platforms - Considerations for EHR/EDC Integration”
Date: Thursday, 23 June 2022 Time: 10.00 am -11.00 am EST
The webinar will explore key considerations related to
- Registry platform planning and consideration
- How EHR data integrated into your EDC can accelerate your registry study
- Optimized Digital Solution through the data coordinating center
As a Clinical Research Organization (CRO), Navitas Life Sciences has been taking profound steps to support better care and treatment for patients with wide ranging illnesses. Our ability to unravel the biological complexity in diseases and support clinical trials for better therapy, with resilience and agility, has brought in newer perspectives. Reach out to our Industry leading experts for tips and insights to bring your life-saving medicines to the market quickly and efficiently.
On-Demand Webinar: Dont Treat Your Registry like your Clinical Trials
Listen to our On-demand webinar as our subject matter experts explores key themes regarding
- How Registries are different from Clinical Trials?
- How to effectively support the development of a Registry?
- Which systems and strategies are necessary to develop a successful Registry?
Speakers:
Michael Garber
Executive Director,
Navitas Clinical Research
Yun Lu
Chief Science & Innovation Officer,
Navitas Clinical Research
Sarah Lawrence
Sr. Clinical Project Manager,
Navitas Clinical Research
To find out more about our services and solutions, reach out to us at