Clinical Data Management
Collect valid, high-quality data in clinical trials
Our experienced clinical data managers help you create a solid foundation for gathering consistent, statistically valid data in clinical trials. Ensure full data standard compliance with the correct database setup, thorough guidelines and training, and a validated, user-friendly clinical data management system.
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High clinical data quality is not an add-on
The quality of your clinical trial data is determined at the outset of your clinical research. If data is not collected properly from the start, it is often time-consuming, expensive – and sometimes quite impossible – to sort it out later.
Too many drugs and medical devices never make it onto the market. Not because they do not work, but because the clinical data are inconsistent, statistically invalid, or not compliant with official standards.
Good clinical data management is the foundation of quality data
Good clinical data management (CDM) creates a solid foundation for your data collection.
BioStata’s experienced data managers ensure that your trial protocols are compliant with official standards. They design case report forms (eCRF) and a trial validation plan (TVP) and set up a fully CDISC / SDTM compliant database.
Your clinical research associates can collect consistent, reliable, valid, compliant data, which will speed up the approval process for your medical therapy or device.
Our clinical data management services include:
- Protocol review
- Case report forms (eCRF) in IBM Clinical Development.
- Trial validation plan (TVP)
- Risk based monitoring
- User acceptance testing (UAT)
- Data handling protocol / data management plan
- User training of CRAs and sponsor
- External data transfer specifications
- Query management
- Coding
- Conduct, including reports and status meetings
- Database release and lock
- Data handling report
- Trial master file (TMF)
Some of our clients say:
We have worked with BioStata for three years. They have provided submission-ready data, which enabled us to submit to the authorities ahead of plan. Timely deliveries, quality, commitment, and flexibility are the keywords describing our collaboration.
Jeff Craven
Principal Medical Writer
Contura International A/S
Our CDM services are tailored to
As a sponsor, you get:
- Smaller and medium-sized sponsors in the biotech or pharma industries
- Sponsors who do not have clinical data managers in-house
- Sponsors conducting clinical research of drugs or medical devices
- Sponsors conducting clinical trials in phases 1-4.
- Consistent, easy data collection with a user-friendly clinical data management system
- Thorough training
- Full Title 21 CFR Part 11 compliance
- High-quality data for a speedy approval process
- Reduced risk of data discrepancies and resultant rejection
- Reduced time to market with
- High data consistency due to the use of AI
3 reasons why BioStata is a sound choice as your clinical data management CRO
1. Fast, consistent coding
We use artificial intelligence to reduce coding time and increase data consistency.
2. A Title 21 CFR Part 11 compliant data system
We use the validated IBM Clinical Development system that complies with all FDA requirements to electronic records, ensuring that your clinical data are “trustworthy, reliable, and equivalent to paper records”.
3. A highly experienced team
Our data managers have 15+ years of experience with clinical data management. They know where to focus to ensure the best data quality in the least amount of time.
A sound investment tailored to your needs
We adjust the scope of the clinical data management to suit your needs.
If you wish to add other services such as DMC services, biometrics services or other data assistance, we can give you a competitive quote on the full project, or you can choose CDM only on a time & material basis.
Regardless of your preference, investing in a solid foundation for your clinical data collection will ensure that your data meet all official requirements and increase your medical therapy’s chances of approval.
What to expect from the clinical data management process
Kick-off
Each new project is kicked off with an informal meeting between the data management team and the sponsor. We use this meeting to match expectations about trial outcomes and timelines and understand data priorities.
Stage one: Setting up the database
Our data managers (DM) review the trial protocol and make design recommendations if needed.
We agree on which modules of the IBM Clinical Development system are to be used, how many patients and sites are involved, etc.
Based on the trial protocol, the data managers design the eCRF in the clinical database system IBM Clinical Development.
We prepare a trial validation plan (TVP) describing how data is to be managed. We set up validation checks to ensure that we catch any data not following the TVP.
Risk-based monitoring helps you identify and manage risks at an early stage of your research.
If you choose risk-based monitoring, we will define the source data validation (SDV) level and prepare a critical data point strategy categorizing all the eCRFs and their SDV levels.
Our programmers set up the lists and risk indicators, and we review the SDV levels based on risk triggers.
Stage 2: Testing and training
Testing the database pre-launch is vital to ensuring ease of use. We check that everything from data fields to visit rules to roles work as intended.
We prepare a data handling protocol describing the data management process of the trial.
Our data managers train the sponsor and key clinical research associates on a Train the Trainer basis. This means that they can train new users, reducing the need for CRO assistance.
Stage 3: Launch
The database and the eCRF are activated. Sites can now be created in the database, and trained staff can request access.
Stage 4: Conduct
During the various trial phases, queries are managed, and data are encoded and extracted for lists, reports and status meetings.
If external data (e.g., MRI, central lab data) are to be added, our DMs and programmers agree on data transfer specifications with the external vendors. We review test data and receive production data as agreed.
Queries are automatically prompted once a site enters data that triggers a TVP check. The site must either correct the data or fill in a query reply explaining the data.
The DMs close the query once resolved. Some database roles can manually create queries.
Side effects and diagnoses are coded using MedDRA and medication using WHODrug in the IBM Clinical Development system.
We use artificial intelligence (IBM Watson) to increase coding speed and data consistency.
Stage 5: Database release and lock
The sponsor receives medical coding lists for review. Once they are approved and all queries are closed, the database is released and locked. Data can now be processed by programmers and analysts.
The DMs prepare a data handling report describing the results and any discrepancies from the data handling protocol.
The DMs prepare electronic documents and data according to the DIA reference model structure for submission to the sponsor.
At BioStata, we can also help you with general data management advice, DMC support, data review support and more.