Data monitoring committee services | Full FDA compliance
Ensure full compliance with FDA regulations throughout the clinical trials
BioStata is your reliable CRO in clinical trials with vulnerable populations that require oversight by a data monitoring committee.
You can safely leave everything related to the data monitoring committee (DMC) process to us, from assessing whether you need a DMC for your clinical trial to drawing up a DMC charter, organising meetings and providing biostatistics reports for the committee and interim analyses.
In short, we ensure full compliance with all relevant data regulations, so you can focus exclusively on the clinical trials.
Ensure a fully compliant data monitoring committee process
An increasing number of pharmaceutical companies are relying on experienced contract research organisations like BioStata to manage the data monitoring committee (also known as a data safety monitoring board or DSMB) process in clinical trials with vulnerable populations.
This area of medical research is heavily regulated. Without the properly trained resources in-house you run the risk of violating the regulations, resulting in your medical drug or device not meeting the criteria for approval.
With BioStata as your CRO, you can rely safely on our expertise and experience in managing the research data and the data monitoring committee process during all phases of the clinical trial.
Ensure your blinded status throughout the trial process
We act as the un-blinded link between you as the blind sponsor and the un-blinded data monitoring committee to ensure compliance with all the relevant regulations.
Our long data experience means we look beyond the immediately obvious and might, for instance, uncover reasonable grounds for continuing the trials in the event of a DMC recommendation to terminate the trials prematurely.
What we offer
Choose the full package where we organise and manage the entire DMC process, or select the services you need from our portfolio:
- A full setup, including templates for all the documents needed (DMC charter, minutes, statements etc.)
- Drawing up a data monitoring committee charter
- Organising meetings and minutes
- Handling the un-blinding and production of data packages
- Interim analyses, including futility analyses.
Who we cater to:
Our data monitoring committee services cater to large as well as smaller pharmaceutical companies worldwide conducting clinical trials of drugs or medical devices in vulnerable populations (i.e., high risk populations such as pregnant people, children, or cancer patients).
What you get:
- An experienced data management partner
- A structured data monitoring committee process
- Full compliance with all relevant clinical trial data regulations
- Guaranteed adherence to timelines
- More time to focus on the clinical trials themselves
- A quicker, safer way to bring your drug or medical device to market.
Some of our clients say:
I have always been happy with the work performed by BioStata. Their professionalism and dedication towards each assignment ensure timely deliverables of a high quality. I have used their expertise in administration and data analysis many times in relation to data monitoring committee data, and I recommend their skills and profound knowledge in this context.
Tina Maria Greve
Senior Drug Safety Advisor at ALK
I have the greatest respect for BioStata’s professional and accommodating handling of the DMCs on which I have had the pleasure of working with them.
Graeme Hankey
Chair of several DMCs and professor
Royal Perth Hospital – Stroke Unit
4 reasons why BioStata’s data monitoring committee services are a safe choice
1. Experience you can rely on
You can safely leave the DMC process management to us. We are an experienced contract research organisation and have provided DMC and data management services to more than 50 DMCs worldwide.
2. Your timeline is guaranteed
We guarantee timeline adherence. We do not accept more projects than we can handle, and we offer staff and material backup.
3. You always get the A-team
We deliberately keep our organisation small, and our list of clients limited to ensure that you always work closely with the most talented, experienced people, and we give you and your project our undivided attention.
4. Price range
We pride ourselves on delivering high quality data monitoring committee services at reasonable prices. The price range depends on the scope of the clinical trial project.
The process
FAQ
A DMC (Data Monitoring Committee) and a DSMB (Data and Safety Monitoring Board) are the same thing. DMC is the more commonly used term these days.
The FDA and the EMA use the term DMC in their guidelines on data monitoring committees, whereas the World Health Organisation refer to DSMBs.
A data monitoring committee is a requirement according to FDA/EMA regulations, e.g., when conducting clinical trials in vulnerable populations. We are happy to advise you as to whether those regulations apply to your clinical research.
We do not recommend that the DMC be blind. This is not realistically possible as it would mean denying the committee members access to information necessary to determine whether a clinical trial should be terminated.
To ensure that you, the trial sponsor, stay blind throughout the clinical trials, we act as a link between you and the DMC, unblinding the data for the DMC members.