STUDY TYPE
Phase IV clinical trial
SERVICES
Data management, safety reporting, statistics, project management, medical writing
CLIENT
Not-for-profit
Vaccine clinical trial support delivered under compressed timelines
Building on a 10-year collaboration, P95 provided vaccine clinical trial support for a Phase IV, randomized, open-label study evaluating immune outcomes in 500 infants. Conducted in South Asia, the study aimed to generate evidence following earlier vaccine administration schedules.
The sponsor asked for a four-month acceleration of database closure halfway through the trial. At the same time, key external laboratory datasets were received later than expected and required quick reconciliation and integration within the allocated study budget.
Coordinated multi-service delivery
We used a cross-functional, integrated strategy in several important service areas:
Data Management
- eCRF development tailored to protocol requirements
- Medical coding using standardized dictionaries
- Data cleaning to ensure accuracy and consistency
- Multiple data reconciliations (lab, safety, clinical sources)
- Protocol deviation collection for downstream integration
Biostatistics
- Randomization generation and implementation
- Participation in data review meetings with cross-functional teams
- Statistical analysis and programming of TLFs
Pharmacovigilance
- Safety event reporting in line with regulatory standards
- Serious Adverse Events (SAEs) reconciliation across datasets
Medical Writing
- Clinical Study Report (CSR) development and finalization
- Manuscript initiation for peer-reviewed publication
Project Management
- Budget and timeline oversight throughout life cycle
- Trial master file (TMF) preparation and sponsor submission
Faster internal coordination, fewer handover errors, and the elimination for needing multiple vendor contracts were all made possible by this cross-functional delivery model.
Results and impact: A long-standing partnership
Despite the complicated dataset requirements and the updated timeline, P95 delivered all milestones on time and within budget:
- Database lock was achieved 4 months ahead of schedule
- Final statistical analysis and clinical trial report were submitted on time
- Late-arriving external lab data processed and integrated within 2 working days
- Despite schedule modifications, there was no budget increase
- The sponsor rebooked the same team for a follow-up study, reflecting a trusted relationship built over more than 10 years of collaboration
FAQ
Here are some answers to Frequently Asked Questions.
What challenges are common in clinical trials for not-for-profits, and how did P95 address them in this study?
Vaccine trials for not-for-profits usually face tight budgets, short deadlines, and changing logistics. In this project, P95 managed to meet a faster database closure and handle late lab data, all while staying within budget. Our ten years of working with the sponsor helped us respond quickly and work smoothly as things changed.
How did P95 manage to deliver the trial outcomes ahead of schedule?
P95 used a team approach that brought together data management, biostatistics, safety monitoring, medical writing, and project management. By keeping everything in-house and staying in close contact with the sponsor, we locked the database four months early and handled late lab data in just two days.
What is the significance of long-term sponsor relationships in the conduct of clinical trials?
Long-standing connections facilitate easier collaboration, quicker onboarding, and operational efficiency. In this instance, we were able to anticipate expectations, respond flexibly, and expedite delivery without sacrificing data quality or compliance because of our ten-year engagement with the sponsor.
Can P95 accommodate similar trials with tight budgets or pressing deadlines?
Yes. At P95 we provide integrated, scalable services that are suited to projects with particular limitations, such as tight budgets, tight deadlines, or intricate data integration requirements.
Request more information
Use the form below to contact us.
