Medical Monitoring Services
Medical monitoring is important for conducting good clinical practices in investigator initiated trial (IIT) and clinical trials. Protheragen's quality medical monitoring services are tailored to the specific needs of business and ease the complexity of clinical trials assisted with our wide global network and cutting-edge quality.
Overview of Medical Monitoring
Medical supervision is the continuous observation of clinical studies with a view of preserving the safety, efficacy, and authenticity of the research. It encompasses a cadre of medical experts with profound knowledge in the therapy under consideration which encompasses taking an active part in the operational and strategy level all through the course of the study. These specialists examine and advise on a number of constituent parts of the trial, from the design of the protocol to the analysis of the outcomes, to be certain that the standards required both medically and scientifically are satisfied.
Fig.1 Conduct on-site monitoring during different phases of clinical trials. (Jung S.Y., et al., 2021)
Medical Monitoring in Clinical Research
It is very critical to carry out safety monitoring at all stages, from the creation of study protocols to the analysis of data and data reporting. It is the responsibility of medical monitors to:
- Protocol Review and Design Consultation: Comment on proposals such as the definition of the study population, definition of study objectives, and definition of safety procedures.
- Investigator and Site Support: Providing support and serving as the 'go-to' physician for investigators and study personnel regarding patients, safety issues, and compliance with the study protocol.
- Safety Monitor: Evaluation of adverse events reporting, coding and narratives, making suggestions to the DMC/DSMB to minimize injury to participants.
- Data Review: Periodic review of clinical data e.g. lab results and other medications to detect any unusual patterns or signals that might indicate a safety concern.
Our Services
At Protheragen, we provide highly specialized medical monitoring services to clinical research projects. Our dedicated clinical teams are organized by studies to facilitate customization and ensure that all study monitoring and management activities are performed effectively.
Medical Expertise and Monitor
- Protocol Review and Consulting: Our specialists examine and provide feedback regarding patient recruitment criteria, endpoint definition, feasibility studies, and the selection of clinical sites.
- Medical Monitoring Plan: We devise a specific document outlining the duties of a medical monitor and normalises the interaction with stakeholders to aid in achieving the study objectives, following our standard procedures and templates.
- Therapeutic/Indication Training: Protheragen teaches project teams and site staff so they can learn the medical aspects of the trial for proper execution.
- Investigator Meetings: As part of clinical trials, our medical monitors actively participate in investigators' meetings to ensure everything about the project is understood by all.
Medical Review
- Eligibility Review: As required by the site, our medical monitors assess the eligibility for screening/randomisation.
- Protocol Adherence Review: After randomisation, we have monitoring activities that are routine to ensure compliance with the protocol, i.e. recording of protocol violations.
- Periodic Data Review: We conduct thorough medical monitoring of AE reports, concomitant medications reports, and the coding for data quality.
- Laboratory Data Review: We check and assess the out-of-range laboratory values for data correctness.
- Data Review and Input: We give medical input and review tables, figures, and data so that the presentation of results is correct and complete.
- Regular Review with Sponsor: Protheragen medical monitors conduct regular reviews with sponsor representatives to ensure that unity exists while resolving rising concerns.
Medical Communication
- Site Consultation: Our medical monitors conduct medical consultations with site investigators concerning issues encountered with the subject, such as eligibility, required management, concomitant medications, and any other treatment or study procedures and the investigational product/device.
- Availability: We are available at any time for urgent queries regarding patient safety and health. For urgent, yet non-threatening concerns, our monitoring doctors respond within one business day. Other queries are answered within two days.
Effective quality management is critical to the success and integrity of clinical trials. Protheragen has the capacity to provide drug development lifecycle management services to clients owing to their extensive transformational knowledge within the domain of clinical research. If you are interested in our services, please feel free to contact us.
Reference
- Jung So-Young, Jung Won Kang, and Tae-Hun Kim. "Monitoring in clinical trials of complementary and alternative medicine." Integrative medicine research 10.2 (2021): 100666.
