Medical Management of Clinical Trials
The Research Physician is a key member of any drug development team and forms the backbone for all medical and scientific aspects of clinical research projects. We provide scientific and medical input to all aspects of clinical studies and development programs from concept to conclusion.
Europital’s Medical Monitors form a scientific driving force behind all study phases with 24/7 medical guidance provided to investigational sites and the various study teams to ensure patient safety and scientific integrity of the study. Our Research Physicians perform expert medical review of clinical and safety study documents, the accumulated data and associated reports to ensure the quality of the study, the robustness of the data and the scientific value of the conclusions.
Physician-to-Physician scientific interactions are essential to establish a reliable partnership between Investigators and Sponsors. Europital medical liaisons ensure continuous site engagement via scientific interactions with investigators and site staff that facilitate essential knowledge transfer and resolving of potential obstacles that might impact the study.
- Medical Expertise from concept to conclusion
- 24/7 Medical Monitoring
- Medical Review of documents and data
- Medical Liaison and site engagement
- Medical and Scientific Training
The Study Design phase is a critical part of clinical studies and requires a collaborative effort from the medical, clinical operations, data management, regulatory affairs, and statistics departments. The framework of medical management to be followed throughout the course of the trial is founded during this phase of the clinical study.
Establish Core Study Aspects:
- Study Objectives
- Patient Populations
- Endpoints and Outcome Measures
Medical and Scientific Advice:
- Interaction with Authorities and Agencies
- KOLs and Advisory Committees
Selection of Business Partners
The study set-up phase can be considered to start from the Clinical Trial Application (CTA) to the recruitment of the first patient.
Close collaboration between the medical monitor and the various members of the cross-functional study team members is essential in this phase to build a medical management platform for the duration of the course of the trial.
Development and Review of documents and procedures related to the medical management of the study:
- Protocol, IB, ICF, SAP, DMP
- Medical Management Plan
- Protocol Deviations Guidance
- Safety Management Plan
Provide Regulatory support with responses to CA and IRB/EC
Ensuring the clinical study team are fully trained in all medical-related aspects of the project:
- Protocol Training
- Therapeutic Area and Disease Indication training
- Safety reporting and Deviation Management training
The procedures and pathways defined by the Medical Monitor in the Medical Management Plan, the Protocol Deviations Guidance document, and Safety Management Plan are executed as planned during the study conduct to drive the study progression in the right direction with the aim of meeting study-specific milestones and projections in the process.
One of the primary responsibilities of a medical monitor is to support the study team and sites by providing daily medical guidance under any circumstance and, in the process, to build a knowledge base for the medical and scientific needs of the study, which can be accessed by the whole study team.
Key Medical Activities:
- Medical and Scientific support to investigational sites and various members of the cross-functional operations team
- Eligibility Review
- Management of Medical Questions and Guidance Requests
- Regular Review of Study Data, both aggregate data and individual patient’s data
- Management of Protocol Deviations
- Communication and Escalation
Management and Prevention of Protocol Deviations
Developing a well-prepared Major Protocol Deviations Guidance document by the responsible Medical Monitor, early in the study setup phase enables the appropriate training of all site monitors. Vigilance during the early parts of the trial by collecting and analyzing feedback on the identified deviations from the site monitors, and recommended steps to prevent them, should be in place. A strong operational management approach including regular review of the regulatory binder, consent documents, and source documents minimizes the occurrence of these study deviations. Regular review of the reported deviations by the Medical Monitor should ensure prompt actions when required to guard patient’s safety and, in the same time, establish any applicable corrective and preventive actions to maintain the scientific integrity of the study.
After data entry cut-off for all subjects in the study, the medical monitor holds the responsibility of reviewing the study data that are being presented for accuracy and medical logic. The medical monitor plays a vital role in ensuring the scientific value of the study data and foresee that all raised medical queries have been addressed adequately and satisfactorily answered by study sites, and that clarifications have been provided where needed.
Key Medical Activities
- Data Cleaning
- Standardized Listings
- Smart Listings
- Medical Query Tracker (MQT)
- TFLs Review
- Comments Resolution Tracker
- CSR Review
Medical Review of Case Narratives
Our recommended approach for reviewing narratives is to establish a three-step process of verification, medical review, and quality control (QC). The verification step is to ensure the completeness and correctness by cross-checking narrative content with the source of information in the clinical and/ or safety database. Medical review is performed to confirm the plausibility and medical logic within the narrative content. Finally, a QC by a second medical reviewer checks that the narrative content is ready for finalization
Safety Physician Services
- Safety Management Plan (SMP) Review
- Medical Input and Review of SAE Reconciliation Plan
- Medical Review of SAE/AESI/Pregnancy Report Template
- Develop Medical and Safety Review Report
- Medical Review of Safety Reports (DSUR/PSUR)
- SAE Listings Review
- Medical Review of SAE Initial and FU Reports
- Medical Input and Support Into SAE Reconciliation
- Medical Review of SUSARs and CIOMS Report(s)