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.
Data management
Our data management services are designed to ensure that your data is collected, validated, and maintained with the highest levels of integrity, adhering to all regulatory standards. Our experts collaborate closely with your team to develop study-specific data collection tools, manage eCRF designs, handle external data integrations, and maintain data quality through thorough validation and medical coding.
Partnering with leading EDC and eCOA technology platforms, we empower our clients with the flexibility to deploy the best-suited technology solutions tailored to each study’s unique needs. From protocol development to database lock, P95 ensures a seamless and compliant data management process, helping you navigate the complexities of clinical research with confidence.
biostaTISTICS
In parallel, our biostatisticians are highly skilled at transforming raw data into meaningful, interpretable insights. Our team handles everything from sample size calculations and statistical protocol development to interim analyses, data pooling, and regulatory submissions. By applying robust statistical methodologies and maintaining full compliance with CDISC standards, we provide you with clear, actionable data that drives informed decision-making and ensures the scientific integrity of your studies.
safety management
Our Safety Management Team ensures that the safety of trial participants as well as the safe use of vaccines and investigational drugs are top priorities. Our experts have extensive knowledge and experience working closely with investigators, regulatory authorities, independent ethics committees, institutional review boards, and sponsors.
Medical Monitoring is an integrated part of our Safety Management services. Our medical monitors are involved in any safety-related matters throughout clinical trials. They provide support and guidance for all study team members and sites who can rely on their medical expertise.
medical writing
Medical Writing demands fit-for-purpose writing skills, medical expertise, and up-to-date scientific knowledge. Our team excels in creating well-structured, compliant documents that adhere to ICH guidelines and regulatory requirements, as well as abstracts and reports for publications. Fluent in many languages, we offer a comprehensive range of services, including writing, reviewing, quality control, editing, and translation, for clinical programs, ongoing studies, and real-world evidence.
differentiators
- Dedicated data, analysis and writing experts in vaccines and infectious disease: with experience across 500 clinical trials and 300 epidemiology projects, 75% of which were in vaccines and infectious diseases, we combine our domain expertise knowledge capabilities with scientific excellence
- Flexible solutions and a personalized approach, customized around the individual needs of our clients: we are used to adapting resources to project needs and can tap into a pool of experienced and qualified team members
- A-Z expertise: with in-depth knowledge across a range of clinical trial functions, including data management and biostatistics, safety management, and medical writing, we offer end-to-end support for clinical excellence
- Tailored, flexible support: our clinical trial services adapt with you, so you can choose how much support you need, from individual functions to the full range
- Expert analysis: we deliver the actionable insights you need to make informed decisions
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.