inference Inc. – Biometrics at Its Best

Years of Experience

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Clinical Studies since 2017

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Team Size

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Submissions

Inference delivers end-to-end biometrics expertise for clinical development — a broad statistical strategy that optimizes study design and develops compliant data packages and reports for regulatory submissions. With experience supporting numerous product submissions, especially working with small pharma and biotechs, we understand the demands and efficiencies required for success.

OUR SERVICES

BIOSTATISTICS

At the core we are a statistical company. Our expertise is in statistics as it is applied to all phases of drug development. We do it deliberately, efficiently, and with passion.
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INDEPENDENT STATISTICAL CENTER

The success & integrity of a clinical trial depend on timely, accurate, & unbiased data monitoring. That’s where Inference’s Independent Statistical Center (ISC) team plays a vital role in (illuminating) critical analyses to our DMCs.
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PHARMACOKINETICS

Much of drug development rests on questions about dosing, safety, drug interaction, bridging of formulations and populations, and characterizing the PK profile of the molecule and its metabolites.
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EPIDEMIOLOGY

We offer our biotech partners a range of epidemiological services supporting drug development processes, regulatory approval, post-marketing studies and health technology assessment.
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STATISTICAL PROGRAMMING

Reporting of data to regulatory agencies requires programming of standardized datasets, meaningful and validated outputs and thorough documentation for the reviewers.
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DATA MANAGEMENT

Good inference can only be based on good data, and collecting good data has to be planned properly and executed flawlessly. We provide end-to-end clinical data management services.
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MEDICAL WRITING

Inference's medical writers have years of experience in preparing ICH-compliant study documents from protocol to CSRs to integrated documents for submission.
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WHY INFERENCE

Whether it was for key face-to-face regulatory interactions, on-time delivery of trial TLF’s, or for ad hoc urgent analyses of clinical trial data, Inference’s unsurpassed experience and expertise enabled our clinical development and management teams to make rapid, data-driven decisions. Inference is a valuable and trusted partner.

I say “partner” because that is my perception of Inference’s fundamental working principle. When they take on a project, no matter how large or small, everyone on the Inference Team operates as though the successful completion of each contracted deliverable is their primary focus and “our” success is their success.

Your team has been a pleasure to work with.

Thank you for being proactive in the development of this critical study in such a short timeframe.

...huge shoutout to the biostats team who have helped support deliverables of our project. Because of your team's hard work and dedication, we were able to achieve a significant partnering milestone!

...this is yet another great demonstration of your ability to be flexible, as well as proof that what we do together truly makes an impact in the healthcare industry. You should all feel very proud to be a part of that! Keep up the great work, team.