When it comes to medical services and patient safety, you need a trusted team who will manage the full scope of services at every stage of development. Our medical directors and safety specialists are involved not only in your study’s day-to-day medical monitoring and safety activities, but all pre- and post-study procedures, from study design and protocol development through preparation of your Clinical Study Report (CSR).
Our Expertise
Our global Medical Services team provides expertise in the following areas:
CLINICAL DEVELOPMENT
Our team provides strategic input to your overall clinical development plan, including feasibility and an indication search for new drug candidates as well as assistance planning study designs.
MEDICAL MONITORING
Review of eligibility criteria, address medical related site questions and understanding the overall safety trends in your study while continually evaluating safety data. Our team also develops a medical monitoring plan (MMP) for your study and provides 24/7 medical support.
CLINICAL OPERATIONS SUPPORT
Our medical and safety team closely collaborates with the clinical study team in protocol deviation and study timelines review, communication with investigators, including accompanied monitoring visits. We also review all patient facing materials.
PATIENT SAFETY SUPPORT
Ability to provide a full range of Medical Safety support including Data and Safety Monitoring Board (DSMB) related activities.
DATA MANAGEMENT SUPPORT
Integrating with our Data Management team, providing input into the design of your electronic Case Report Form (eCRF) and support of data cleaning activities including medical coding and patient profiles review.
MEDICAL WRITING SUPPORT
Strong expertise for writing your study protocol and CSR.