Genpro - an independent data coordinating center that you can trust and rely on.
With over 15+ years of industry experience in all aspects of data monitoring committees (DMCs), serving on DMCs as well as acting as the independent statistical group reporting to DMCs. Our lead Statistician will be your primary contact and will work with programming and project management to ensure all reports and deliverables are in place for the DMC.
Genpro’s operating procedures abide by the FDA’s guidance document for DMCs.
Management and operations
- Developing a DMC charter.
- Nominating experts to be on a DMC.
- Managing DMC meetings: scheduling, creating agendas, preparing minutes with recorded sessions.
- Encouraging communication between the sponsor and the DMC to have a better understanding of ideas.
- Facilitating the DMC’s recommendation to the sponsor
Archiving DMC materials until the study is unblinded.
- Writing interim analysis plans, including statistical methods and table shells.
- Developing statistical stopping guidelines for efficacy, futility, and safety.
- Proposing the appropriate analyses for ad hoc DMC analysis requests
- Programming analysis datasets with interim data.
- Creating planned and ad hoc presentations for the DMC.
- Preparing and presenting unblinded safety and efficacy reports.
- Preparing blinded sponsor reports.
Our approach to DMCs
GENPRO takes an active role while reporting to a DMC by providing DMCs a clearly written report that assists the members in assessing the risks and benefits of the interventions being studied. We scrutinize and study the data being collected, understand the disease endpoints, safety profile, and trends or patterns in lab data observed in the study or suspected for the class of agent.
Our goal is to have the DMC members get the tables, figures, and visuals readily interpretable and well organised.
Relationship with the sponsor and the DMC
As per the regulatory needs and independent nature of DMC reporting, we strive to:
- Build trust and strictly follow the DMC charter in all our interactions with DMCs
- Securely transferring study materials,
- Prompt and professionally manage all DMC requests.
- Managing communications among the sponsor, the data provider, and the DMC
- Properly store and distribute electronic materials adhering to SOPs and regulatory requirements.
Our goal is to ensure the interests of the sponsor, the investigators, IRBs and Ethics Committees, and regulatory agencies are maintained.
Interim analyses and group sequential design
We strive to provide the all reports accordingly that the interim data provides the evidence of either efficacy or futility of the drug/combination or device.
- With 10 years of experience reporting interim results to DMCs that allow for early stopping of the study.
- Communication with clients and DMCs to analyse and present the data necessary for an informed recommendation.
- Guide the discussions and provide the information that may be pertinent questions DMC members may ask.
- Complex Innovative Designs like Bayesian Analyses and Adaptive using conditional power, predictive power, and sample-size recalculation.