CTC announces licensing of Pinnacle 21 Enterprise™
Clinical Trial Consultants (CTC) is the first CRO in Scandinavia to adopt Pinnacle 21 Enterprise to ensure CDISC adherence and delivery.
CTC announced today, on June 20 2022, that it is the first CRO in Scandinavia to adopt a leading data validation software, Pinnacle 21 Enterprise by Certara, and is thereby fully licenced for high-quality data deliverables in CDISC format.
Pinnacle 21 Enterprise is a leading tool to validate clinical study data, including its content and format. The tool verifies that data packages comply with CDISC standards (SDTM, ADaM and SEND), controlled terminology, and dictionaries like MedDRA and WHODrug.
“Making sure that the database and associated descriptive specification documents meet the requirements is a prerequisite when submitting to the FDA, and Pinnacle 21 is an essential tool to help us get fit to submit”, says Calle Joachimsson, Delivery Specialist at CTC.
The software is used by 23 of the top 25 global pharmaceutical companies to prepare clinical data for submissions to regulatory authorities such as the FDA, PMDA (Japan) and NMPA (China). Furthermore, the FDA and PMDA use Pinnacle 21 Enterprise to enable the agencies to perform large-scale data validation and data quality reporting.
The Pinnacle 21 Enterprise used by Clinical Trial Consultants (CTC) is the commercial version of the software that has a track record of many successful, global regulatory submissions.
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.
About Clinical Trial Consultants
CTC was founded in 2011 and is a full-service CRO with the mission to facilitate clinical and translational research by providing the customers with cost-effective advice, conduct and reporting of clinical trials. CTC offers clinical trials in phase 0-IV as well as medical device trials and has offices in Uppsala, Lund and Stockholm including four own clinical research units.