Solutions to ensure patient safety and study integrity throughout your clinical trial.
We can support across a variety of scenarios, from providing independent DMC statisticians to delivering a full Statistical Data Analysis Center (SDAC) with administrative support.
Through expert guidance and transparent collaboration, we help you safeguard patient safety and maintain study integrity while saving time, money, and resources. You can rely on us to deliver high-quality results that keep your trial running smoothly from setup to closeout.
We put people and quality first. We have a 90%+ retention rate ensuring consistent and always ensure experienced SDAC members oversee your trial needs. By proactively resourcing, we provide the expertise, rigorous monitoring, and reliable support needed to maintain data integrity and patient safety throughout the study.
We map out every detail, including roles, data flows, logistics, and timelines, so your DMC runs smoothly and delivers quality results.
Your DMC is supported by statisticians with experience across a variety of therapeutic areas who are familiar with the unique statistical and logistical issues of interim analyses and DMCs.
We protect the study blind with GCP‑compliant processes and secure data handling, safeguarding both scientific validity and regulatory compliance.
We act as a trusted extension of your team, communicating clearly and adapting quickly to requests, study changes, or data challenges.
Statistical Data Analysis Center
Our hands‑on statisticians and programmers have extensive DMC experience in a range of therapeutic areas. They ensure data quality, maintain the study blind, and deliver accurate interim analyses, even with incomplete or evolving data. Supported by robust processes and technology, we provide reliable results without compromise.
Charter support
Our SDAC statisticians have extensive experience of managing DMC charters. Our teams can support review and input into draft charters or lead the development of the DMC charter, including incorporating review comments from all stakeholders and leading discussions on the charter at DMC organizational meetings.
Administrative and Logistical Support
As a part of our end-to-end service, we take on the burden of administrative and logistical support for the DMC. For example, we can set up and host virtual DMC meetings, make logistical arrangements for secure face to face meetings, manage secure file transfer and storage, as well as manage and organize the on-going project management of the DMC process.
DMC Statisticians
When we’re not otherwise involved in your study, we can provide experienced statisticians to serve as the DMC’s statistical member, in either a voting or non‑voting role.
A Data Monitoring Committee (DMC) comprises a multidisciplinary group of experts who periodically assess the accumulating safety and, where applicable, efficacy data of an ongoing clinical trial. The DMC protects the safety of participants and the scientific integrity of the study, advising the sponsor on study modification, continuation or termination. To avoid bias, the DMC is external to the trial and independent of the sponsor.
Not all trials need a DMC, but where they do the DMC allows the sponsor and investigators to fulfil their responsibilities in overseeing the conduct of the trial whilst protecting the integrity of the trial and maintaining the blind.
It may not be ethical to wait until the end of the trial before assessing the efficacy and safety of the treatments under study, such that interim assessments are required to protect the safety of ongoing and future trial participants. Another example is where a study may have preplanned interim analyses to support decisions on early stopping (either for futility or positive efficacy) or design adaptation (for example dropping a treatment in an umbrella design), requiring assessment of unblinded results whilst the study overall is blinded. To avoid the potential for bias or undue influence on subsequent trial conduct, an independent Data Monitoring Committee is used for such interim monitoring of unblinded/aggregate safety and efficacy results.
A DMC requires administrative and logistical support to set up, timely access to relevant (usually unblinded) analyses of accumulating study data during the study, and statistical support. These should also be independent of the sponsor and are services we can provide.
A DMC is crucial when interim assessments are needed to ensure participant safety or guide trial decisions. It helps avoid bias by independently reviewing unblinded data and making recommendations without influencing ongoing trial conduct.
Veramed uses GCP-compliant processes and secure data handling to protect the study blind and maintain regulatory compliance. Our approach safeguards scientific validity while ensuring ethical oversight throughout the trial.
Yes, Veramed’s statisticians and programmers have extensive experience supporting DMCs across a wide range of therapeutic areas. Our teams are trained to handle the unique statistical and logistical challenges of interim analyses and DMC operations.
Veramed provides full administrative support including virtual and in-person meeting setup, secure file transfer and storage, project management, and logistical coordination to ensure smooth DMC operations throughout the trial.
Other acronyms commonly used to describe a Data Monitoring Committee include DSMB (Data and Safety Monitoring Board), IDMC (Independent Data Monitoring Committee), and SRC (Safety Review Committee). While terminology can vary by region or organization, these terms all refer to independent groups responsible for reviewing safety and efficacy data to protect participants and maintain trial integrity.
