Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | Clinical study sponsors |
| Work | Site start-up, monitoring and study-document coordination |
| Rules and standards | Study protocol and applicable GCP requirements |
1. STUDY START-UP
Study start-up support includes feasibility review, site selection and participant recruitment planning.
The study team reviews the following start-up activities:
● Evidence-based feasibility
● Carefully evaluated and selected position
● Identify and evaluate potential bottlenecks to create effective risk reduction strategies
● Clinical trial validation and legal documentation
● Collect and review site management documents
● Procurement of regulatory and/or ethics committee approvals
● Organize and hold investigator meetings
● Website initialization and rapid audience recruitment
2. CLINICAL MONITORING
Clinical monitoring is planned against the study protocol, monitoring plan and applicable good clinical practice (GCP) requirements. Availability and visit schedules are agreed for each study.
What we offer our partners:
● Visits start the site
● Frequent site monitoring visits
● Site management and easy access - including regular site contact via phone, email, etc.
● Monitor the query resolution process
● Website support during database locking
● Research observational visits
Contact HMC to discuss study-specific monitoring needs.
3. SITE MANAGEMENT
Site management supports study documentation, recruitment tracking and protocol coordination.
Clinical research associate (CRA) responsibilities and availability are agreed for the study.
Resources and tools that HMC offers you during your studies are:
● Training and educating site staff
● Research of drug and non-drug supply logistics
● Keeping track of regulatory document revisions
● Monitoring protocol deviations
● Subject state tracking in trials
4. SAFETY MONITORING
Safety monitoring follows the agreed study plan.
Medical monitoring responsibilities and availability are defined for each study.
Strategic services that HMC provides:
● Medical supervision planning
● Performance of medical surveillance inclusion/exclusion criteria
● Therapy area training for CRA and PM
● Assistance in SAE (Serious Adverse Event) reports to investigators
● Interaction with the Data Safety Monitoring Board (DSMB)
● Distribution of secure information reasonably among investigators
● Announce safety notice to regulatory authorities and/or ethics committee
5. CLINICAL TRIAL LOGISTICS
To make your trial go smoothly, our clinical trial logistics will:
● Apply for import and export permits from regulatory agencies
● Prepare customs documents
● Import research products, comparators, and research materials, including laboratory kits and any specific equipment
● Store, distribute, relabel, return, and destroy investigative materials/equipment.
● Export biological samples from clinical sites to the central laboratory
● Management of courier services
6. VENDORS' MANAGEMENT
Laboratory and other provider qualifications must be confirmed for the specific study.
Service information adapted from the original source ↗.
Read the original website record