BioStata | Statistical consultants

Statistical consultants for clinical trials

Ensure valid research data from phase I to final submission and reduce time to market with BioStata’s statistical consultancy services.

Contact us for a preliminary consultation

Why use statistical consultants in clinical trials?

Objective, statistically valid research data are critical to proving the effect of a drug or device in clinical trials.

Nine times out of ten our statistical consultants uncover faults in the study design or protocol which can have severe consequences in the form of inadmissible data, submission delays, additional questions from medical authorities, and, ultimately, the drug or device not being approved at all.

Ensure data compliance with experienced statistical consultants

BioStata’s team of experienced statistical consultants help you navigate the complexity of clinical trial statistics, prevent data errors, meet regulatory requirements and deadlines, and reduce your medical therapy’s time to market.

Our statistical consultancy services include:

Receive submission-ready data

Our statistical consultants work closely with our competent team of various clinical data experts to ensure that you produce and receive objective, submission-ready data.

Our statistical consultants assist:

As a sponsor, you get:

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

3 reasons why our statistical consultants are a good choice:

1. Experienced

Our statistical consultants are highly experienced and deliver quality work regardless of your budget.

2. Flexible

We are used to the unpredictable nature of long-running clinical trials and strive to adapt to changing deadlines and project scopes.

3. Transparent

At BioStata, we only sell you what you need, and we are transparent about our methods throughout the process.

Invest in a solid statistical foundation for your clinical trial

We adapt our statistics service offer to match your budget.

In close collaboration with you, we define the scope of the project and any additional CRO services required to help you meet regulatory data standards.

What to expect from our statistical consulting services

Step 1

Preliminary meeting

Together, we define the scope, budget and timeline of your project and match expectations.

Step 2

Protocol review

Our statistical consultants review your study protocol to ensure compliance with regulatory requirements. Nine times out of ten they uncover issues that could lead to problems later in the process. They also advise on sample size, estimands, end points, study design etc.

Step 3

eCRF review

Our statisticians review the electronic case report form (eCRF) to ensure that the endpoints are correct. The eCRF is then checked against the protocol, and any inconsistencies are addressed.

Step 4

Risk-based monitoring

The statistical consultants check the data quality as part of the risk-based monitoring strategy we recommend.

Step 5

Database lock (DBL)

We check the data quality and answer questions while the study is still blind to ensure objectivity in the results.

Step 6

Validation and programming

We use parallel programming to validate the calculations. This is the most thorough and reliable way to ensure that the programming – and hence the results – are correct.

Step 7

Presentation of results

Once everything is validated, our statistical consultants can help present the results of the clinical study to the sponsor´s management department.

Step 8

Input to clinicaltrials.gov

We provide the sponsor with statistical data inputs for the required report to clinicaltrials.gov within the deadline.

Step 9

Submission-ready data and documentation

We supply a statistical report and submission-ready, fully CDISC-compliant data as well as documentation for the authorities.