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Clinical Trials
Our team has extensive experience in supporting all aspects of clinical trials, from clinical protocol development and site start-up to ongoing site and vendor management and clinical study report development and site close-out.


 

Clinical Trial Support

PLC has extensive experience in supporting all aspects of the clinical trial process from clinical protocol development to managing the clinical trial process and achieving registration of new products and indications with the FDA. With our clinical strategy development, we offer guidance at each step of the process to ensure compliance. Our ability to facilitate development under our partner umbrella gives our clients access to senior level support without the need for costly separate contracts.

Preparation

Write protocol – develop the protocol with KOLs and Pis, negotiate a protocol with the FDA, obtain scientific and IRB approvals at sites
Site selection – identify and evaluate site qualifications, build relationships with the investigators
Create documents – IRB related, CRFs
Manage IRB submissions, approvals, and amendments
Site initiation
Site contracts and budgets
Manage trial conduct directly through contract CRAs and Data Management
Evaluate and negotiate proposals from CROs
Direct access to medical/technical writing
 

Trial Management:

Train the site coordinator, monitor and pharmacy
Track enrollment
Oversee site invoice payment and tracking
Assist with disclosing payments made as reportable under the Sunshine Act
DSMB – chose members, organize charter and hold meetings
Manage the conduct of the CRO
Oversee management of Trial Master Files
 

Safety Management:

Central Medical Monitoring capabilities – clinical site management of medical issues, collection of safety data, interpretation of events
Regulatory reporting – SAEs, Annual Reports
Safety auditing – internal procedures, safety data, FDA readiness

Clinical Trial Areas