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Top Highlights from 2022 - Five Exciting Studies You Don’t Want to Miss
From working on therapy for COVID-19 to Parkinson’s disease clinical registry, it has been quite a thrilling and exciting year for clinical trial management, clinical registry, regulatory services and pharmacovigilance. In this blog, we look back and present some of the studies that helped shape the past year, through interesting case studies, while including a dash of insights to showcase our expertise.
1) Adaptive design for a global Study for a First-in-Class Therapy for Critical Covid-19 Patient
Navitas Life Sciences provided end-to-end support to a US Based mid-size biotech company in the development of their first in class therapy for critically ill covid patients. The Phase I study had been conducted in the US, and the company needed a partner to conduct the Phase II study in multiple countries - USA, India and other potential countries.
Navitas Life Sciences’ experienced Medical writers, Medical Leads and Biostatistics teams collaborated to deliver a well designed innovative and adaptive, two stage study protocol within a short span
Adaptive design for a global Study for a First-in-Class Therapy for Critical Covid-19 Patient
Learn how we:
- Developed a robust study protocol
- Completed the study in a short span
- Received Appreciation from the USFDA
2) Providing End-to-End IND Regulatory and Medical Writing Services
Our client, headquartered in the USA, is a mid-sized biopharmaceutical company specializing in clinical-stage precision therapeutics as they work to meet the needs of patients suffering from oncology and autoimmune related diseases.
“My father had his first heart attack when I was 13 and when I was 17 he had a 10 hour open heart surgery at a time when there were only 6 physicians in the country performing open heart surgeries. From then on, I was always interested in medicine but didn’t think I had the academic "chops" to succeed and I didn’t have anyone to encourage me. I was working as an office manager in a neurology office when the PI urged me to train as a study coordinator and that was it, I was hooked. Almost 30 years later I’ve had a wonderful career.”
Director, Program Management
The client was seeking US FDA approval for a Phase I clinical study to be conducted in the USA and needed to prepare and file an eCTD dossier to support the IND Application. With a predefined, and very short submission window, the client engaged with Navitas Life Sciences to provide End-to-End IND Regulatory and Medical Writing Services.
Providing End-to-End IND Regulatory and Medical Writing Services
Find out how we supported the successful delivery of the IND submission in a very short period of time. The IND application was accepted by the US FDA and acknowledgment received with the client receiving a ‘Study may proceed’ letter within 3 weeks.3) Managing a complex PV engagement by leveraging safetyREADY to deliver process optimization:
Our client a mid-sized global pharmaceutical company headquartered in South Korea is developing new biologics and innovative drugs. They were seeking a partner to support them in activities relating to ICSR case processing, regulatory submissions, and translations.
Our client is regularly conducting Observational/Post-Marketing Surveillance (PMS) Studies. As a result, Adverse Events (AEs) from these studies are returned as bulk cases in batches of ~500 to 2500 as line listings from the clinical database. In addition, there is a requirement for spontaneous cases to be processed and submitted. Both the bulk and spontaneous cases necessitate the translation of source documents from Korean to English, all within a short timeframe and while adhering to committed and demanding turnaround times.
Managing a complex PV engagement by leveraging safetyREADY to deliver process optimization
learn how we submitted to the Ministry of Food and Drug Safety (MFDS)
- ~2500 cases
- meeting the Regulatory timelines
- with 100% quality record
- In 7 days
4) Intelligent and Unified Data Analytics and Aggregation for 5 Clinical Trials, from 3 CROs, and 3 EDC Platforms using OneClinical Analytics
Our client a global clinical-stage biopharmaceutical company headquartered in New Jersey, USA, was seeking a partner to help aggregate clinical trial data from 5 different clinical studies, being managed by 3 different Clinical Research Organizations (CROs) and using 3 different Electronic Data Capture (EDC) systems.
Intelligent and Unified Data Analytics and Aggregation for 5 Clinical Trials, from 3 CROs, and 3 EDC Platforms using OneClinical Analytics
Learn how we worked with our client to unify data analytics and aggregation across 5 clinical trials, 3 CROs, and 3 varied EDC platforms utilizing OneClinical Analytics to power intelligent study oversight and medical monitoring.
5) Successful Registry and Data Coordinating Center Support for Parkinson’s Foundation’s Parkinson’s Disease GENEration Registry
The Parkinson’s Foundation (PF) works towards improving care for people with Parkinson’s disease (PD) and people at risk of developing PD and advancing research to find a cure. The foundation has a multi-center community and offers genetic testing to create a genetic data and sample repository. This registry program also provides genetic counselling to the participants. The PF required the services of an experienced clinical research organization as the Registry Coordinating Center supporting their large genetic registry program.
Successful Registry and Data Coordinating Center Support for Parkinson’s Foundation’s Parkinson’s Disease GENEration Registry
Streamlined process and support to over 90 sites
- Provided efficient and effective data management and quality control
- Ensured successful Integration of the clinical data of nearly 2000 patients with the genetic data
- with 100% quality record
- Shared data sets with The Global Parkinson’s Genetics Program (GP2), National Institute on Aging (NIA) and Michael J Fox Foundation
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