Delivering focused support where you need it

Research Documents Drafting

Drafting of protocol, informed consent and other research documents to make sure they meet the latest regulatory standards and are formatted to perfection. Assisting with submission of research documents to IRB for review and approval.

Study Monitoring

Routine site monitoring for safety, compliance and study protocol adherence. Preparation for audit and site qualification visits. Help with regulatory documents management.

Establishing systems and procedures

Help with evaluating current systems and with configuration of new systems as well as writing of necessary Standard Operating Procedures (SOP) and guidance documents.