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.

Compliance, Collaboration, Control: Streamlining the Development Process.

Code and approve clinical trial data from any device and keep your safety and efficacy data clean, consistent, and ready for analysis.

Early Phase Experts

As a full-service contract research organization, Southern Star Research has the knowledge, industry relationships and technical expertise to get your early-phase clinical trial up and running safely and efficiently.

With a broad range of experience delivering Phase 1 Healthy Volunteer, First in Human, First in Patient and Phase 2 trials, we know just how important it is for your asset to succeed in the early development lifecycle. Our experienced team will help you obtain high-quality data that will appeal to future investors, meet the requirements of international regulatory bodies such as the FDA, EMA, PMDA, and Health Canada, and prepare your product for larger Phase 3 and 4 studies, partnerships, licensing, and sale.

Whatever your clinical trial needs, we can provide a flexible, bespoke solution that will not only meet your regulatory requirements but also position your product for commercial success.

Experience higher data quality, retention and participant compliance by providing a truly engaging experience from data submission to reminders, appointment management, telemedicine and more -- from the phone, tablet, or desktop.

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

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.

What can 22,000 people with an AI-mindset accomplish?

Speed without shortcuts

AI in clinical development at Parexel enables our teams to surface predictive insights at every stage, reducing protocol risk, study delays, and costly trial amendments.

Parexel's approach to AI in clinical development is built on the Precision Pathway, a strategic operating model that embeds AI across the full trial lifecycle. AI empowers our teams at critical decision points to:

1. Simplify complex tasks to accelerate timelines: AI capabilities are delivering up to 50% cycle time reductions in IND submission generation.
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