CRO Biostatistics Services

Delivering High-Quality Biostatistics Services in Support of Your Clinical Trials

As a full-service and functional service biometrics CRO, we offer a full suite of Biostatistic Services to support your clinical research needs.

In order for your compound to move to the next stage of development, your data must be flawless. You have spent potentially millions on this study, and it is critical that your biostatistics partner provides you with actionable quality data to inform your decisions and your clinical study report.

By using advanced statistical methodology, while maintaining a laser focus on quality and timeliness of your data, our biostatistics team ensures you receive the most robust analysis and presentation available for your data.

Whether you need full-service project execution or stand-alone services, you will receive study data that’s delivered on time and with meticulous attention to detail. You can be confident that our experts have every aspect of your clinical trial covered, across all therapeutic areas from design to final submission.

Impeccable Data Integrity

A Focus on Quality Throughout the Biostatistics Process

To make sure you receive the most accurate data possible, we build a stringent system of checks and balances into every step of our biostatistics process so that delivery and quality always go hand in hand.

Analysis plans that meet International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use guidelines
Benefit from enhanced innovation, reduced cost and streamlined processes in adherence with the latest standards thanks to Pharm-Olam's gold member status with the Clinical Data Interchange Standards Consortium (CDISC)
Extensive quality control (QC) with peer review twice processed (independent) production and validation programming with a Pinnacle report run on your data every time we deliver a draft.
Finally, a lead statistician and senior reviewer examine all calculations and statistical outputs; ensuring you receive the highest level of precision, efficiency and data integrity

Biostatistics Services List

Your CRO biostatistics service provider needs to have a robust list of services to cover you throughout your compounds lifecycle. We have a wide range of biostatistical tasks and services designed to support your development program.

Our team provides statistical tasks such as:

Efficient, cost-saving study designs
Sample size calculations
Randomization services
Data Monitoring Committee support
E-submission ready statistical packages
SAS programming support (ADaM, SDTM, etc.)

No matter what kind of clinical trial you have, our biostatistical services have you covered. For a full list of our services, see below.

End-to-End Biostatical Services

Planning

Biostatistical Consultancy
Study design
Study simulation
Data integration and regulatory submission strategies
Protocol/SAP development
NDA briefing document preparation
Health Authority meeting preparation, attendance and review
CS standards specification mapping
Randomization plans

Execution

Database and TFL production
Statistical methodology application
Adaptive design and study execution support for studies with missing data
Risk/benefit assessment
Datasets and TFL production to CDISC and non-CDISC standards
Outlier detection

Reporting and Submissions

Key result and statistical assessment expert review
Key result reporting
Cross-study safety and efficacy data integration
CTD summary document input
Electronic dataset and documentation generation
Rapid response support
DMC/DSMB reports
ECRF review and annotation

Biostatistics In Action

“The quality of the data and the quick turnaround time for query resolution enabled us to complete the clinical trial and integrated clinical statistical report on time while meeting the aggressive timelines required by this project.”

Biotech - Director of Clinical Operations

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