The involvement of Medical Monitoring (MM) and Data Safety Monitoring Boards (DSMB) in trials has been somewhat unknown to individuals outside of clinical circles. That is, until media attention during the current pandemic spotlighted their impactful decisions on COVID-19 treatments and vaccines. These news stories illustrate the go-no-go decisions on trials sponsored by large and small pharma, all aiming for COVID-19 therapies and cures. A great deal of hope rests on the success of clinical trials, hope for the benefit that the drug or product will bring to patients and their loved ones, improvement of world health, and desire for company financial success that can be applied to future pipeline vaccines and therapeutics.
Many sponsors and drug companies already know that ProPharma has been providing GxP consulting, regulatory affairs, clinical and postmarketing pharmacovigilance, and medical information services for 20 years. What some may not know is that we also work closely with Contract Research Organizations (CROs) to enhance their ability to support their management of Investigator Sites and clinical trial data.
Our Clinical Services team actively manages a network of physicians who review clinical trial data in the form of independent DSMBs and Medical Monitors. These physicians and committees review subject eligibility, study participation progression, and weigh the efficacy and safety of the trial against the data that is collected and make the difficult decision to continue with the protocol as written or not. Clinical trial sponsors and CROs often find benefit in utilizing an independent company to provide safety reviews and objective and unbiased decision making. These are crucial oversight requirements by health authorities during a clinical trial or safety data review. We focus our efforts on maintaining, managing, and coordinating a network of experienced physicians so that our CRO clients can focus their time and attention on managing clinical trial timelines and sponsor expectations.
ProPharma's experts work symbiotically with CROs and extend their capabilities offered to sponsors by providing Medical Monitors and DSMB members to contribute to their clinical trials in the form of this independent review.
Our Medical Monitor physician services include:
- Assisting with the development, review, and approval of the Medical Monitoring Plan.
- Providing guidance with respect to treatment of any reactions as outlined in the protocol, and other clinical or regulatory guidance as needed.
- Advising on laboratory panic or alert values and study Serious Adverse Events (SAEs).
- Interacting with the site and Sponsor to determine if any findings (AEs or lab data) warrant further subject workup to better understand an event in relation to concomitant medications or drug allergies.
Our DSMB services include:
- Providing experienced pharmacovigilance physicians and statisticians to serve as the Chairperson and voting members for the DSMB.
- Providing protocol review and consultation; charter development, review, and approval, initial charter meeting, data review, data review meetings, and ad-hoc reviews and meetings.
- A dedicated DSMB Project Manager who will be responsible for member contracts, maintenance of the Charter, distribution of DSMB materials, maintaining the SMC documents, coordinating teleconferences, attendance for meetings, creation/distribution of meeting minutes, and coordinating reviews and communications.
Our established project management tools and collaborative approach streamline the process of facilitating meetings, documents, schedules, and other project logistics. This saves CROs valuable time and effort and expands their ability to fulfill their clients’ needs. In addition to supporting the physician monitoring activities, our Clinical Services team has direct access to a global spectrum of compliance, regulatory affairs, pharmacovigilance, and medical information experts.
ProPharma has the capabilities and experience to coordinate and manage the DSMB and provide independent medical reviewers through our extensive pool of physicians. As with each of our Clinical Services projects, a dedicated Project Administrator is assigned to serve as point person and act as the conduit between the client and the project members. To expedite our services, ProPharma maintains established procedures and templates that may be used to facilitate the creation of many of the essential documents, such as confidentiality agreements, conflict of interest statements (or lack thereof), DSMB charters, medical monitoring plans, and safety management plans. This administrative support provided by ProPharma allows for the client to focus on executing successful study protocols and activities at the investigator sites.
To connect with our Clinical Services experts, contact our team today!
