Biometric services for clinical trials
Get fully valid clinical research data and reports
Our experienced biostatisticians, data managers and programmers set up and conduct the reporting of the biometrics in your clinical trial, ensuring that the research data meet regulatory standards, and results are valid.
Contact us for a free consultation
Keep your clinical trial on track from start to finish
A thorough, methodical data handling approach is crucial in all four phases of clinical trials.
Accidental unblinding, invalid results, or datasets not meeting regulatory standards
can set the clinical trials back weeks, months, or, in some cases, years.
At worst, such mistakes lead to your medical therapy or device not being approved for sale.
Professional biometric services ensure data quality
BioStata’s experienced biostatisticians, data managers and programmers keep your clinical trial on track throughout phases I, II, III and IV.
We are a CRO specializing in biometrics services such as CDISC compliance, Clinical Data Management (CDM), statistical programming etc.
With our expert help, you ensure that all your clinical research data are valid, meet regulatory standards, and are ready for submission on time.
BioStata’s biometric services:
Some of our clients say:
I have worked with BioStata for several years now. BioStata are flexible and know how to navigate in a busy world of changing deadlines while maintaining the high standard of their work.
René dePont Christensen
Vice President Biometrics
Y-mAbs Therapeutics, Inc.
We provide biometric services for:
4 reasons why BioStata is a reliable biometric service partner
1. We’re small, but sound
We continuously grow our expertise rather than our size to ensure the personal customer focus and high-quality service for which we are renowned. Our sound finances are your guarantee that we can take on even long-running studies and deliver throughout all phases of your trial.
2. You matter to us
We care about every one of our customers and take the time to understand you and your medical drug or device in depth.
3. Our handpicked experts are at your service
The biometrics experts at BioStata are among the most talented and experienced in their field. We choose only the cream of the crop to offer you biometric services of the highest quality.
4.Your investment in biometric services
We adapt the scope of the biometrics services to your needs and the requirements of your clinical research.
You only pay for the services you need.
What to expect from the biometric services process
Together, we define the scope and requirements of your clinical trials. You receive an estimate of the time and biometrics services needed.
The kick-off event sets the foundation for a good partnership. As the sponsor, you get to meet the team and explain the objective and priorities of the trial.
The sponsor provides a study protocol, which our experts review and validate. If necessary, we suggest changes.
We describe the statistical model for the database and set up the electronic case record forms (eCRF).
Our experienced data managers train your team in the correct usage of the data management system.
We map data for analysis in compliance with regulatory standards such as CDISC SDTM and create table shells.
This includes a statistical analysis plan with table figure and listing shells. Table figure and sistings are programmed.
As part of the statistical reporting, we hold key result meetings to discuss any issues of relevance and provide inputs to your Integrated Clinical Statistical Trial Report.
We also offer MW via partner and statistical CTD support for final submissions of entire projects (ISS and ISE).