Biostatistics

Customizable biostatistics based on respected industry standards

Encorium biostatisticians are well versed in all aspects throughout Phases I to IV, giving you valuable continuity across the program. Our biostatisticians are experienced in communicating with regulatory authorities and can therefore support you with your statistical enquiries to them.
SAS® software is used for all statistical analysis and reporting. Encorium follows ICH reporting standards, adjusting them specifically to your study. SAS programs are fully tested before the database is closed, which gives the advantage of rapid delivery of your results.

Accurate data management at any scale

Cost effective and accurate data management are key assets in Encorium’s data services. In the last two years, Encorium has processed over 1 million CRF pages with an error rate below 0.02%.
From small Phase I studies to large Phase III and IV trials with over 60,000 subjects, Encorium is powered by Clintrial™ and a range of EDC systems. We are approved for both paper-based and electronic record keeping. All applications are validated to comply with 21 CFR Part 11 guidelines. Our staff are trained in Good Clinical Data Management Practices (GCMP) and we work in compliance with CDISC standards.

Efficient management of committee requests

Encorium understands the process and function of Data Monitoring Committees and Endpoint Adjudication Committees. We have proven expertise in overseeing these committees and meeting critical DMC timelines.
Encorium has experience in providing data to DMC meetings, both scheduled and ad hoc. Our staff are familiar with the issues that are often encountered in such meetings, and serve information so that DMC members can perform their duties efficiently. Encorium has performed statistical services in trials with DMC activities as trial statistician, independent statistician supporting DMC work, or as a DMC member.
 

Contact Us

For enquiries on Encorium's services and capabilities, please contact info@encorium.com alternatively contact your local Encorium operations (see the site location map).

Encorium Headquarter

Encorium Oy
Keilaranta 10
FI-02150 Espoo
Finland
Tel: +358 20 751 8200
Fax:
Clinical Department
+358 20 751 8250
Administration
+358 20 751 8255
info@encorium.com