Get through your clinical trial on time with an experienced CRO on your team

A speedy approval process is the goal for any clinical trial. But it takes extensive expertise to keep a clinical trial on track from start to finish. With a contract research organization onboard, you can reinforce your in-house capabilities with external resources without breaking your budget.

Why choose BioStata?

Years of industry experience

Skilled specialists dedicated to your project

Comprehensive biometrics services

A flexible approach to problem solving

Biometrics services tailored to your requirements

BioStata was founded in 2010, and ever since our goal has been to help sponsors worldwide submit fully compliant clinical research data in all four phases of clinical trials.

With specialists within biometrics services such as CDISC compliance, clinical data management, statistical programming and data monitoring committee processes, you can get the support you require to avoid setbacks.

With handpicked industry veterans and an adaptable approach, you get professional and methodical data handling fitted to your exact requirements.

“I have always been happy with the work performed by BioStata. Their professionalism and dedication towards the assignments ensure timely deliverables of high quality. I have used their expertise many times when it comes to administration and data analysis in relation to the Data Monitoring Committees data, and can recommend others to use their skills and profound knowledge in this context,”

Submission-ready data for a swift approval

Submitting anything but completely compliant clinical data can draw out the approval process, costing you time and money.

However, collecting and structuring data in accordance with the CDISC standards is challenging and requires extensive expertise within biometrics – something most smaller enterprises lack in-house.

At BioStata, we offer full CDISC services – from advising you on the best strategy to collect your clinical data to readying your data for submission.
Usually, we work with a 3-step process.

First, we determine the scope and time frame of the clinical trial. Secondly, we help you retrieve the necessary data. Thirdly, we assess the data quality and conform it in accordance with the CDISC standards.

With our CDISC services, you are assured:

Guaranteed CDISC compliance

FDA submission-ready data

Reduced risk of time-consuming follow-up questions

A swift approval process

Reduced time to market

Efficient and consistent clinical data management

High-quality data should never be exclusively for the sponsors with the deepest wallets and unlimited resources.

Quality data is the foundation for a successful clinical trial, but to collect great data, you need efficient clinical data management.

BioStata helps you collect consistent, reliable, valid and compliant data, ensuring you control of all your data from start to finish.

By listening to your requirements and budget, we adjust our scope to fit your needs.

Our CDM services gives you:

A user-friendly clinical data management system

Thorough training

High-quality data for a speedy approval process

Reduced time to market with

Reduced risk of data discrepancies and resultant rejection

High data consistency due to the use of AI

Full Title 21 CFR Part 11 compliance

Experienced statistical consultancy services

Experienced statistical consultancy services

Upholding the time frame and budget of any clinical trial is a top priority, and valid data is paramount to achieve a speedy process or even reducing your time to market.

BioStata’s experienced statistical consultants help you ensure data compliance and take on the responsibility of preventing data errors, meeting regulatory requirements and deadlines.

Our broad statistical services include; protocol reviews, statistical advice, study designs, sample size calculations, definition of estimands, statistical analysis plans (SAP), clinical data analyses, data validation and interim analyses.

In addition, our statistical consultants use their industry insights to uncover potential faults in the study design or protocol, allowing you to rest assured that your study is designed for success.

With our statistical consultancy services, you receive:

Statistical consulting adjusted to your budget

Full data compliance

Submission-ready data

A speedier approval process

An objective, outside perspective

Fully compliant data monitoring committee (DMC)

The stringent regulations surrounding clinical trials that might involve vulnerable populations or be associated with significant safety concerns can be difficult to uphold.

Without properly trained in-house specialists, you risk violating the regulations or not meeting the requirements for approval.

At BioStata, we provide you with extensive industry insights in managing research data and in the data monitoring committee process during all clinical trial phases.

You get the safety of knowing that your study remains in compliance and that your blinded status is protected.

With BioStata, you can get help to ensure:

  • A full setup, including templates for all the documents needed
  • Drawing up a data monitoring committee charter
  • Organising meetings and minutes
  • Handling of the unblinding and production of data packages
  • Interim analyses, including futility analysis.
  • Guaranteed adherence to timelines
  • Full compliance with all relevant clinical trial data regulations
  • More time to focus on the clinical trials themselves

“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.”

Your data security is our priority

Clinical data security is non-negotiable, and we ensure you that safe and compliant data is one of our main concerns.

But it can be expensive to store your data securely in-house. At BioStata, we help you make sure that your clinical data is kept in accordance with regulatory requirements as well as relevant guidelines and standards.

This helps protect sensitive data, minimises the risk of errors and inaccuracies and ensures you trustworthy, reliable and compliant data.

Should we assist you in your clinical trials?

Fill out the form to schedule a meeting where we can discuss your current or upcoming trial.

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