Clinical Operations
MD Pharma Consulting Group supports medical monitors observing the conduct of clinical trials in accordance with “Guideline for Good Clinical Practice E6 (R1)”. Support services provided to medical monitors include:
1. Prepares checklists for the diverse medical monitoring visits including:
- Site selection visits.
- Site initiation visits.
- On-site and remote site monitoring visits.
- Study close-out visit.
2. Workshops that deliver advanced training on:
- Site selection visit.
- Site initiation visit.
- Clinical trial protocol.
- On-site and remote monitoring visit.
- Study close-out visit.
3. Ensures that protocol deviations are minimized proactively.
MD Pharma Consulting Group supports sponsors requesting periodic or ad hoc audits to evaluate clinical trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.
Audit services provided to sponsors include:
- Prepares audit SOP.
- Implements external periodic or ad hoc audit.
- Workshops that deliver advanced training on internal periodic or ad hoc audit.
MD Pharma Consulting Group supports sponsors and industry partners on medical consulting projects through our collaborative network of licensed Canadian and British physicians specialized in diverse therapeutic areas.
MD Pharma Consulting Group follows the conduct of our clients' clinical studies.
Data management services provided to our clients include:
- Manages the electronic data capture (EDC) systems ensuring proper EDC.
- Designs and develops the study’s Case Report Form (CRF) / eCRF based on the study protocol.
- Works on the data specifications for the clinical and safety databases.
- Codes the medical terms using MedDRA.
- Codes medications using WHO Drug Dictionary.
- Communicates with the research sites regularly for queries, safety inquires, and missing information.
MD Pharma Consulting Group liaises with all stakeholders to promote and manage our clients’ products. We reach out to the KOLs, regulators, investigators, clinical data coordinators, clinical research associates, Institutional Review Board (IRB) and Data Safety and Monitoring Board (DSMB) making sure that our provided professional services are quality assured and maintain compliance with the “Guideline for Good Clinical Practice E6 (R1)”.