Navigating drug safety in the era of innovation-driven medicine

The focus on drug safety and pharmacovigilance has never been more intense. Patient safety remains paramount throughout a product's lifecycle, even as sponsors and marketing authorization holders (MAHs) face increasing complexity in managing safety data. This complexity stems from huge volumes of data generated from scores of diverse sources, much of it rapidly expanding unstructured data. Innovation-driven medicine is a key factor. These dynamics are reshaping the landscape of drug safety, presenting both challenges and opportunities for innovation in pharmacovigilance practices.

Biostatistical services, including SAP development, statistical programming in SAS, analysis, submission-ready services and statistical reports are customized and designed specifically to meet your project requirements.

Trial@home, CHDR’s dedicated strategy for off-site clinical trials, enables investigators to collect information as trial participants go about their day to day activities.

Zelta’s EDC has been used in more than 4,000 studies from startup to submission, across all phases, including over 500 phase 3c trials and 23 therapeutic areas.

Accelerate Medical Writing Without Compromising Accuracy or Compliance

In the fast-paced world of clinical research, the ability to produce, review, and finalize high-quality documents—on time and with full regulatory compliance—is non-negotiable. Ideagen Document Review (formerly known as PleaseReview) is the trusted collaboration and co-authoring platform that enables clinical teams to streamline document reviews, reduce version chaos, and ensure traceable, auditable feedback across the board.

ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

Speed without shortcuts: AI in clinical development

Our vision is to develop AI solutions that enable faster delivery of new medicines to patients.

AI in Clinical Development is at the core of Parexel’s approach to accelerating first-time quality and milestone delivery through our strategic operating model, Parexel Precision Pathway. We’re committed to the development of innovative, high-value use cases for AI in clinical trials. AI empowers our people at critical decision points and our AI investments prioritize process optimizations that:

1. Simplify complex tasks to accelerate timelines
2. Apply insights with agility to enable better decision-making
3. Enhance data handling to drive first time quality through content generation and workflow automation.

Avance Clinical’s data management team has gained a world-class reputation for accuracy, precision, and quality of their biostatistics and pharmacokinetic (PK) analysis.