Investigative Site Network

Therapeutic areas

metabolic & endocrine disorders

hypertension and cardiac conditions

gastrointestinal diseases

renal disease

respiratory diseases

dermatology

rheumatologic disorders

CNS

FEASIBILITY

Using standardized primary care medical records databases we are able to perform clinical trial feasibility in very short timeframe. Reviewing ICD 10 codes of primary care patient  population we are able to provide accurate feasibility data that match study protocol inclusion criteria.

SITE SELECTION

Prior joining the MedSource Investigative Site Network, sites are carefully selected to meet industry standards criteria. Depending on experience primary care physicians are qualified as Principal Investigators or Sub-Investigators. Site staff is trained on GCP, MedSource Standard Operating Procedures and Clinical Trials Management System. We do our best to minimize the time needed to start the study.

MedSource Coordinators are responsible for smooth setup of all sites participating in study, to meet sponsor requirements for the trial.

CONTRACTING AND LEGAL SUPPORT

MedSource Investigative Site Network have Master Service Agreements with primary care sites, what reduce the Sponsor’s efforts to contract the study and negotiate the budgets. Our legal support assures that all agreements are compliant with sponsor requirements and local laws.

STUDY COORDINATION

For each study MedSource assigns study coordinator, who is responsible for day-to-day contact with site investigators and staff and sponsor study teams. We implemented “one-stop-shop” services to minimize the sponsor time contacting the sites.

QUALITY ASSURANCE

Delivering a high quality data is our priority. We pay much attention to assure quality standards within our network. Each member of the research teams receives a regular comprehensive training in Good Clinical Practice, national and local regulations, latest regulatory requirements. We aim to standardize research processes using our Standard Operating Procedures and Clinical Trials Management System. We conduct regular internal on-site quality audits and address corrective and preventive action if problems are identified.