Clinical Biostatistics Services Built into Every Study

Without interpretation, data is just numbers. Precision applies biostatistics to deliver insight into every phase of your trial. We begin with study design, tailoring a statistical analysis plan to your needs. Our seasoned biostatisticians and statistical programmers analyze that data throughout your trial, and our Data Monitoring Committee keeps watch. Together, we ensure that your data provides critical insights and your submissions meet all regulatory requirements.

Clinical Biostatistics Services Built into Every Study

Without interpretation, data is just numbers. Precision applies biostatistics to deliver insight into every phase of your trial. We begin with study design, tailoring a statistical analysis plan to your needs. Our seasoned biostatisticians and statistical programmers analyze that data throughout your trial, and our Data Monitoring Committee keeps watch. Together, we ensure that your data provides critical insights and your submissions meet all regulatory requirements.

Statistical Consulting

Expert biostatisticians and statistical programmers craft detailed plans, including precise definitions of endpoints and descriptions of analyses, to address regulatory risks and maximize success from the outset.

Study Design

Biostatistics presents specialized challenges for study design. Precision proactively integrates translational sciences and addresses issues from sample size to statistical methodology.

Data Monitoring Committees

We help determine whether your study will benefit from a data monitoring committee-then ensure that all data meets exacting standards through carefully selected committees that oversee every step of data generation and usage.

CDISC Programming and Documentation

Detailed tactics, including annotated CRFs, use of validated macros and specification files, and annotated Pinnacle 21 reports, maximize efficiency and ensure compliance.

eCTD Submissions

We plan from study outset to meet data exchange standards and have timely submission – ready datasets, resulting in a track record of 100% data submission acceptance by the FDA and EMA.

Biostatistics are integral to our clinical trials

Integrated expertise fuels your biostatistics CRO

To reap the full benefit of biomarker-driven studies, you need ongoing biostatical insights. Our team of more than 50 biostatistics experts review your study design, protocols and CRF. Based on those findings we leverage unparalleled data science to create a detailed statistical analysis plan.

We select statistical methods, define endpoints, hone analysis populations. Using ongoing data development and refinement we identify issues and trends throughout the course of your study, then deliver a CDISC package with data sets, reviewer’s guides and detailed analysis.

Our consultative approach goes beyond the individual study

We consider the needs of the study, the regulatory process, the Sponsor company. Elizabeth Ludington, Senior Vice President, Biometrics, explains.

Case Study: Biostatistical analysis leads the FDA to change an orphan drug ruling

In rare inherited metabolic disorders, predefining the best endpoint to demonstrate efficacy of a new treatment can be challenging. We worked with one sponsor who was developing such a treatment. When results from the placebo-controlled clinical trial proved unimpressive, the contract research organization (CRO) that conducted the trial, satisfied it had followed the established statistical analysis plan, concluded there was nothing further to be done.

The sponsor then turned to Precision to see what could be salvaged from the data. We recognized immediately that the study’s established primary endpoint simply was not the best metric by which to judge success. Our task was to secure FDA approval for the drug based on the new proposed efficacy endpoint.

Discover how our clinical biostatistics services can advance your international clinical trial

Discover how our clinical biostatistics services can advance your international clinical trial

Clinical Trial Services

Clinical Trial Management

Fully integrated biomarker-driven trial management solutions-from study start-up through full-service execution-help accelerate your path to approval.

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

Clinical Trial Design

Advanced trial-design approaches-including basket, umbrella, and adaptive trials-deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.

Clinical Sample Management

Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.

Global Clinical Trial Footprint

Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

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