Study Start-Up

Study start-up delivered at speed

When it comes to getting your innovation to patients in need, a well-defined and speedy study start-up strategy is key to advancing your clinical trials. Setting the foundations for successful patient enrollment, we work with trial sites and regulatory bodies to ensure compliance and secure approval to begin enrollment and give patients access to vital drugs.

Our local teams execute global start-up strategy through coordination of regulatory and ethics submissions, ensuring ICH GCP compliance through provision of essential documents, negotiation and execution of site contracts.

We have local knowledge and familiarity with country-specific regulations across the globe, and tools that enable us to retain, share and proactively manage these requirements.. We have well-established standard operating procedures (SOPs), tools and templates in place to simplify and accelerate your project wherever possible.

Our ownership mentality

From the moment we partner with you, we bring an ownership mentality to everything we do, treating your project as if it’s our own and taking active responsibility for delivering the best possible outcomes within timelines, budget and of high quality.

Collaboration and knowledge-sharing

Understanding your therapeutic area is critical for a successful partnership, which is why we are on a continuous mission to grow our knowledge and support you in more meaningful ways.

Our internally developed functional intelligence tools help us to foresee and overcome potential, country-specific, regulatory and start-up considerations and requirements, and ensure our team’s knowledge of regulatory environments remains up to date.

By collaborating closely across feasibility, project management, clinical operations and regulatory strategy teams and maintaining constant communication, we ensure your project involves the right people, at the right time to complete study start-up at speed.