Your CRO partner should drive operational efficiency. Worldwide Clinical Trials Project Management owns and is intimately engaged in every aspect of your clinical trial. You can rely on your Project Management team to expertly guide our joint project team in capturing all relevant data to support your study goals—with clinical and medical integrity.
Supervision comes from your therapeutically aligned Worldwide Project Director, who provides ongoing training, support, and review of the clinical data from an operational perspective in consultation with Medical & Scientific Affairs. Our Project Directors have the experience and expertise to offer operational solutions to the toughest project challenges and ensure your project is delivered on time with quality.
Project Directors are accessible at any time during the conduct of the study. Their involvement begins with the proposal and continues through evaluation and selection of qualified sites, right up to the “last p value.” We believe this dedication and insight can only come from our depth of therapeutic expertise and is core to ensuring rigorous management and mitigation of clinical trial risks.
Special features of Worldwide Clinical Trials Project Management include:
- Preparation of study materials such as the protocol, case report forms, and informed consent documents
- Establishing necessary documentation for IRB and/or Ethics Committee approval
- Preparation and support during initial meetings with the FDA and other regulatory bodies
- Pre-investigational visits to train site staff on the protocol, study materials, applicable regulations, and Good Clinical Practice
- Frequent reports and communications to keep you apprised of data accrual and quality on a site-by-site basis, and to assist in keeping the study team on track