Trial Management and Monitoring Assistance
Critical to a successful clinical trial is the efficient management and monitoring of clinical sites. Medrix Clinical Research ensures scientific excellence and data integrity across all sites. Medrix Clinical Research engages a diverse range of specialized people to perform all aspects of site management and monitoring throughout our many operational centers and regional hubs.
Site Management Services include:
- Site selection and feasibility
- Development of recruitment criteria
- Managing patient recruitment
- Inbuilt quality assurance mechanisms
- Assurance of Good Clinical Practice (GCP)
- Communication with sites/Sponsors/CROs
- Customizable training based on the needs of the study
- Managing of local ethics review processes
- SAE reporting on time and maintained documentations
- Central Lab logistics & sample flow
Clinical Trial Monitoring activities include:
- Full service monitor visits – qualification, initiation, routine, and close-out
- Comprehensive monitor plans
- In country expertise for feasibility or regulatory submissions
- Thorough review of site records
- Timely completion of visit reports
- Quality review of monitor reports
- Source document verification as per monitor plans
- Rapid query resolution
- Site training and support
- Site management support and documentation
- Periodic remote EDC review
- Drug accountability
- Coordinate monitoring & Audit Visits
Post Trial activities:
- Coordinate close out visit
- Resolve data queries on time in coordination with Investigators/Monitors
- Trial Documents Archival (Medrix Clinical Research have own Data Archival Facility)
Patient Recruitment and Retention plan
Successful recruitment has a significant impact on the clinical trial timeline. According to research data, recruitment accounts for 70% of clinical trial delays. Improving patient recruitment rates offers a major opportunity to speed up the clinical trial and product registration. Medrix Clinical Research (SMO) provides qualified PI and site staff to ensure Recruitment and Retention of trial patients from sites.
Patient Recruitment:
- Identify the patients from Inpatient/Outpatient data base from Hospitals/Institutes based on Protocol requirements.
- Identify patient recruitment strategies based on our understanding of the patient's pathway.
- Develop patient recruitment plan to boost recruitment while trying to retain patients in the study.
- Identify the cause of recruitment failure and lost follow up, and provide risk mitigation plan.
- Physicians referrals
- Advertisement when applicable
Patients Retention
- Make patients feel listened to, valued, and supported throughout by listening to patient sentiment.
- Support with logistics such as travel and expenses to reduce the level of inconvenience patient’s experience.
- Use accessible, easy-to-understand language to effectively communicate with patients at every stage.
- Provide timely for visits scheduling avoid to inconvenience to the patients
- Provide the contact detail to patients or caregivers for any medical emergency.
Regulatory Services
Our team is experienced regulatory and safety professionals with the regional knowledge (including local language and culture) and contacts needed to communicate effectively with the appropriate regulatory agencies. Medrix Clinical Research regulatory services can assist sponsors through the varied local regulatory and ethical requirements to ensure the most efficient start-up of a clinical trial.
Our service provision is flexible and can be structured to best fit your needs. Such services include:
- Preparation and submission of clinical trial applications to regulatory authorities and facilitating ongoing regulatory requirements
- Supporting investigators with the preparation and submission of Institutional Review Board or Ethics Committee documentation and facilitating completion of ongoing Institutional Review Board or Ethics Committee requirements
- Regulatory safety reporting
- IEC Registration
Medical Writing
We understand the complexity and importance of Medical writing and we have the experts for preparation of scientific documents our Medical Writer Team closely works with scientists, doctors and other subject matter experts.
Insourcing
Because Clinical Research is conducted in a dynamic environment, it is important to ensure we have sufficient manpower. Medrix Clinical Research has extended its insourcing capacity to support clinical research manpower needs. We strive to be your trusted partner by providing a clinical research staff and functions tailored to your needs. We integrate a wide range of services with highly experienced staff. We provide insourcing staff clinical trial assistant, clinical research Coordinators.
Trainings Programs
We bring the best clinical research professionals to conduct training programs in Ethics in Clinical Research and (ICH-GCP) Good Clinical Practices in Clinical Research for all levels of site staff. We work with sites to customize the training programs to meet the needs.
