CLIENT
Biotech
THERAPEUTIC AREA
Vaccine, infectious disease
SERVICES
functional service and full-service delivery
Solving Complex Data Management and Biostatistics Challenges in Vaccine Clinical Trials
A mid-sized biotech company that develops vaccines for infectious diseases encountered increasing operational and regulatory challenges as its clinical trial program expanded. Timelines were shrinking, coordination became more difficult with evolving regulatory demands and the need for regular analyses added even more pressure.
They needed a partner who could maintain momentum, starting with data and statistical deliverables, but flexible enough to grow with the program. A partner that collaborates well with other vendors, one that can adjust to changing priorities, and can support more studies without sacrificing speed or reliability.
Scaling from Single Study Support to a Functional Service Partnership Model
Our partnership began with data management and biostatistics for early-phase studies. As our client’s pipeline grew, our partnership evolved into a functional service preferred partner, adding pharmacovigilance, monitoring oversight, and broader operational responsibilities.
Our functional service partnership included:
- Starting with data management and biostatistics for early-phase studies
- Acting as a strategic partner in a multi-vendor setting
- Adding pharmacovigilance and monitoring oversight as needs changed
- Offering responsive consultation and problem-solving throughout the lifecycle
- Ensuring consistency in statistical design and analytical standards
- Meeting tight deadlines for post hoc analyses and regulatory requests
A 15-Year Partnership: Expanding to Full-Service Delivery and Market Approval
Over 15 years, we supported more than 20 projects growing from functional support to a trusted full-service partnership for vaccine clinical trials. Highlights include:
- Supported successful regulatory submissions vaccine licensure approvals across major authorities
- Helped our client achieve vaccine registration and fulfill post-marketing commitments in multiple regions
- Expanded to full-service support for multiple studies and post-marketing commitments
- Adjusted delivery models to support growth, speed and cost-effectiveness
- Scaled delivery to a portfolio of more than 10 active studies, globally
- Became the preferred partner for flexible, responsive and reliable support
FAQ
Here are some answers to Frequently Asked Questions.
What services did P95 provide?
In this case study, we began with data management and biostatistics, then grew into full-service clinical trial delivery. This included project managment, clinical monitoring, regulatory, pharmacovigilance and vendor management.
What made this partnership successful?
Flexibility was crucial. Over the years, we scaled from one study to managing more than 20 projects, without compromising speed or consistency. Our ability to adjust and deliver under pressure made the partnership effective.
How is P95's full-service partnership for vaccine clinical trials different?
Unlike traditional providers, we don’t take weeks to implement changes. For instance, when a new regulatory requirement arose during the trial, our senior experts quickly organized a call and modified the protocol within a few days, helping the client stay on schedule.
Does P95 support submissions to regulatory authorities?
Yes, P95 assists sponsors with their regulatory submissions. In this case, we helped facilitate submissions to EMA, FDA, Health Canada, ANVISA and UK MHRA.
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