PLYMOUTH MEETING, Pa. — Pinnacle 21, the leading provider of clinical data standards software and subject matter expertise to the life sciences industry, today announced the availability of a comprehensive set of expert clinical data lifecycle services.
Pinnacle 21, known for their Pinnacle 21 Enterprise software used by FDA, PMDA and clinical trial sponsors to validate and document CDISC clinical data for electronic regulatory submissions, is expanding their current service offerings to include full service clinical data standardization consulting and outsourcing services.
In conjunction with this expansion of SME-driven services, Pinnacle 21 is announcing a partnership with ACI Clinical. The collaboration is designed to join ACI’s trusted biostatistics and clinical programming services with Pinnacle 21’s novel data standardization consulting and outsourcing services, enabling sponsors to leverage industry-leading expertise across the entire clinical data lifecycle.
Max Kanevsky, CEO of Pinnacle 21, commented, “By launching our new expert service offerings and simultaneously partnering with ACI, we are responding to a critical and unmet market need. Our customers have continued to ask for additional services to complement our software. We are pleased to extend our expertise to help build their capabilities.”
Mark Williams, vice president of Data Services, ACI Clinical, added, “The ACI and Pinnacle 21 partnership enables sponsors to take advantage of a full array of expert consulting and outsourcing services that fit any resourcing strategy, budget or timeline. Over the past 15 years, we have accumulated deep experience and expertise helping sponsors prepare their trial data for electronic regulatory submissions and can help build or improve capabilities or fill in the gaps to help clinical trial sponsors meet their regulatory submission goals in the most efficient way possible.”
Tom Guinter, vice president of Clinical Data Services, Pinnacle 21, added, “From clinical data governance to managing the FDA data standardization plan, our service offering is driven by the same clinical data standards subject matter expertise that made Pinnacle 21 Enterprise the industry leading clinical data validation and documentation tool for sponsors and health authorities alike. Our deep standards domain knowledge and enabling technologies fuel our expert services.”
Pinnacle 21 service offerings and partnership with ACI Clinical are being announced at the Drug Information Association 2016 Annual Meeting in Philadelphia, PA. Attendees can visit the Pinnacle 21 exhibit booth (#2403) to learn more about the partnership, the new services, or see a demonstration of Pinnacle 21 Enterprise.
About Pinnacle 21
Pinnacle 21 is the leading provider of clinical data standards software and subject matter expertise to the life sciences industry. The US FDA and Japanese PMDA leverage Pinnacle 21 Enterprise to validate and review clinical data submitted in electronic regulatory submissions according to the CDISC SDTM and ADaM standards. Pinnacle 21 is a platinum member of CDISC and actively participates in numerous CDISC teams and activities. Learn more at www.pinnacle21.net.
About ACI Clinical
ACI Clinical is a specialty provider of clinical trial advisory services and clinical trial committees, such as Endpoint Adjudication and Data Monitoring Committees. ACI has been a CDISC-registered solution provider for many years and maintains deep involvement in several public-private thought leadership efforts to improve the quality and effectiveness of clinical trials. ACI actively participates in current projects with the Cardiac Safety Research Consortium (CSRC), the Clinical Trials Transformation Initiative (CTTI), and the Multi-Regional Clinical Trials Center (MRCT).