ensuring data integrity.
Good clinical and safety data are the cornerstone of clinical research and the key to making a difference to global heath.
At P95, our experts ensure data integrity and safety, and we deliver expert statistical analysis and medical writing that turns your clinical and safety data into meaningful, actionable insights. With specialist expertise in vaccines and infectius diseases, our approach is supported by robust data management practices, industry-leading biostatistics expertise, rigorous safety management, and comprehensive medical writing services.
Data Integrity from Start to Finish
Advanced Biostatistical Expertise
Comprehensive Clinical Documentation
p95: Data, Analysis and Writing solutions in vaccines and infectious disease
At P95, we understand that high-quality data, analysis and writing is critical to the success of any clinical trial or observational study. We ensure that high-quality data management, precise biostatistics, rigorous safety management, and expert medical writing are integral to every project.
P95’s data management and biostatistics, safety management and medical writing teams ensure data integrity and insightful analysis for vaccines and treatments across all stages of development, from protocol writing, eCRF design and database management, to pharmacovigilance and safety surveillance, to complex statistical reporting and regulatory compliance, and to publications and study reports.
flexible
data & Stats
safety & writing
why us
Flexible Multifunctional Support for Clinical Excellence
Whether you need complete data management support, specific statistical analysis, safety solutions, or expert medical writing, P95 delivers accurate, reliable results that drive success in clinical research.
We understand that clinical research can be challenging and unpredictable, so we offer a flexible model that adapts to your clinical study’s needs, ranging from full project outsourcing to functional service models to staff augmentation to consulting.
This gives you access to our functional expertise: we offer a complete package for any study, or any combination of services. This includes data management, biostatistics, clinical safety and pharmacovigilance, and medical writing.
how it works
Our data management team guarantees that all clinical data is collected, validated, and maintained with the highest standards of integrity.
Our biostatistics experts turn raw data into actionable insights, providing clear, interpretable results that support decision-making and regulatory compliance.
Our pharmacovigilance team can support you from auditing and quality assessments to post-marketing and clinical safety.
Our medical writing team ensures that all clinical documents and publications are meticulously prepared, adhering to regulatory requirements and scientific standards.
services
Data Management
Protocol support, eCRF design, database setup, data validation, coding (MedDRA, WHOdrug), medical reviews, SAE reconciliation, metrics reporting, database lock, and more.
Medical Writing
Clinical study documents (protocols, reports), patient safety narratives, regulatory documents, scientific publications, conference communications, educational material, drug safety documents, patient education and outreach, meeting reports, reference management, standard operating procedures, investigational medicinal product dossiers.
Biostatistics
Sample size and power calculations, statistical analysis plans, programming and report generation, support for DSMB/IDMC, interim and final analysis, and conversion of legacy data to CDISC standards.
Safety Management
Preparation of Safety Management Plan, 24 / 7 Safety Desk, SAE Management, Data Entry in Safety Database, Query Management, Expedited Reporting (SUSAR Management) including Eudra Vigilance Reporting, Annual Safety Reporting (DSUR), Participation in Data Safety Monitoring Board Meetings, Medical Monitoring.