At Ardent Clinical Research Services (ACRS), our Medical Monitors play a critical role in ensuring the safety, scientific validity, and ethical conduct of every clinical trial. They are highly qualified physicians with in-depth therapeutic knowledge and regulatory understanding, dedicated to maintaining the highest standards of clinical research.
Provide continuous medical supervision throughout the study lifecycle—from protocol development to study close-out
Act as the primary medical point of contact for clinical teams, investigators, and sponsors
Ensure that all medical aspects of the study are conducted in compliance with ICH-GCP, local regulations, and ethical standards
Collaborate with the clinical and scientific team in designing scientifically sound and feasible protocols
Review and validate study protocols, investigator brochures, and informed consent forms (ICFs) for clinical and medical accuracy
Provide input on inclusion/exclusion criteria, study endpoints, and risk-benefit assessments
Conduct ongoing review of subject safety data, including: Adverse Events (AEs), Serious Adverse Events (SAEs), Laboratory values, ECGs and other diagnostics
Identify any emerging safety signals or trends during the trial and recommend corrective actions if needed
Review protocol deviations and assess their clinical significance
Ensure timely and accurate review of all SAE reports
Provide clinical narratives and medical opinions for regulatory reporting
Respond to medical queries from investigators, ethics committees, and regulatory authorities
Serve as a medical advisor for investigators during site initiation, recruitment, and treatment phases
Provide guidance on protocol adherence, subject safety, and therapeutic area questions
Conduct training sessions for investigators and study staff on protocol, safety reporting, and clinical conduct
Participate in Data Safety Monitoring Board (DSMB) meetings or internal safety review committees
Provide expert opinions on benefit-risk profile, study continuation, or modifications during interim analyses
Collaborate in drafting or reviewing: Clinical Study Reports (CSRs), Safety narratives, DSURs, PSURs, and PBRERs
Contribute to publications or presentations, ensuring data is clinically accurate and ethically presented
Support regulatory submissions by providing clinical input in response to queries from CDSCO, US FDA, EMA, MHRA, and other agencies
Attend regulatory meetings, teleconferences, or audits as needed to provide medical justifications
Evaluate protocol-related medical risks and recommend mitigation strategies
Uphold the rights, safety, and well-being of study participants as a top priority
Ensure that subject confidentiality and ethical standards are maintained across all sites
Highly experienced physicians across multiple therapeutic areas including oncology, neurology, gastroenterology, infectious diseases, and more
Extensive knowledge of clinical trial regulations and Good Clinical Practice (GCP)
Trained in clinical pharmacology, safety surveillance, and clinical trial ethics
Collaborative, responsive, and committed to scientific integrity and participant safety