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Regulatory

Unlock Global Market Access with Expert Regulatory Affairs Services

REGULATORY

SUPPORT

Our Regulatory Affairs support is designed to navigate the regulatory requirements of today's global market seamlessly.

 

With our expertise and support, including specialized roles like Designated Individual and UK Representation, you can focus on innovation and growth, knowing your regulatory obligations are expertly managed.

STRAGEGY DESIGN

Ensure your clinical trial is valid by getting us to take care of your sample size / power calculations.

PROTOCOL DESIGN

Our experienced team can review, contribute to and review study protocols, ensuring that the right questions are being asked from the start.

VIGILANCE

Selecting the right statistical method is critical for your clinical trial. Thanks to the size and diversity of our team, we’ve been involved in a huge range of studies, so we can help you avoid common problems.  We can create statistical analysis plans that meet your required specifications. This could include the details of calculations, layouts and dummy tables.

UK Responsible Person

We have worked on both blinded and unblinded regulatory studies. If independence is what you need to give your trial additional gravitas and meet regulatory requirements.

PERFORMANCE EVALUATION

We can create Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets from specifications to CDISC standards, then develop study appropriate Tables, Figures and Listings (TFLs). As an FSP, we can provide all three of these services, or you can select individual ones to meet your unique requirements.

ANALYSES

Once an initial regulated study is completed and its associated data becomes available for other uses, we contribute to providing the data and assist with further analyses subject to the appropriate data application. We can also help support you with your own data and research question, whether that be within a trial, or perhaps an observational study.

CHAT

LET's

Email Us Now to Discover How We Can Elevate Your Regulatory Together.

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