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:

Protocol input including advice on trial design, sample size calculation etc.
Randomization, e.g., code list, envelope handling or via IWRS
CDISC data mapping
eCRF setup
Clinical data management (CDM)
Statistical planning, including statistical analysis plan, table-figure and listing shells
Statistical reporting, including key result meetings
Integrated clinical statistical trial reports and statistical reports
MW via partner
Statistical CTD support

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:

You get:

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

Step 1

Preliminary meeting

Together, we define the scope and requirements of your clinical trials. You receive an estimate of the time and biometrics services needed.

Step 2

Kickoff

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.

Step 3

Protocol validation

The sponsor provides a study protocol, which our experts review and validate. If necessary, we suggest changes.

Step 4

Setting up the database

We describe the statistical model for the database and set up the electronic case record forms (eCRF).

Step 5

Training

Our experienced data managers train your team in the correct usage of the data management system.

Step 6

Data mapping and table shells

We map data for analysis in compliance with regulatory standards such as CDISC SDTM and create table shells.

Step 7

Statistical planning and programming

This includes a statistical analysis plan with table figure and listing shells. Table figure and sistings are programmed.

Step 8

Statistical reporting

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).