Cyntegrity’s indication focused MyRBQM® RACT library helps clinical research teams speed up and optimize the risk identification and assessment process. Therapy specific RACTs enable study teams to generate risk management plans faster and easier, and be well-positioned for study audits.
The Generic TransCelerate Spreadsheet
In 2013, the non-profit TransCelerate organization coupled its “adaptive approach to clinical trial monitoring” methodology with additional materials including a planning document (Integrated Quality Risk Management Plan – IQRMP) and a template of 70 questions (Risk Assessment and Categorization Tool – RACT) to be answered for each trial to assess the impact, probability, and detectability of risk that might turn into an issue at a given trial site. Where ‘risk’ was defined as something that might happen in the future, and ‘an issue’ as something that was currently happening (or had already happened) at a given trial site.
Cyntegrity further enhanced the original spreadsheet-based RACT and incorporated a user friendly logic into its cloud-based RBQM platform shortly after. Cyntegrity’s constantly growing MyRBQM® RACT library currently holds 10 therapy specific RACT catalogs, in addition to the universal TransCelerate RACT.
Cyntegrity’s Indication Focused MyRBQM® RACT Library
Many risks in clinical trials are therapeutic area-specific. The MyRBQM® RACT catalogs emerge in response to the large number of challenges that today’s clinical research faces. Specific subject safety risks, adjudication risks, therapy cycle risks (i.e. Oncology), disease-specific outcomes and subject enrollment risks are explicitly addressed by Cyntegrity’s indication focused MyRBQM® RACT catalogs.
MyRBQM® RACT – world’s first indication focused RACT catalogs
- Built on the original TransCelerate spreadsheet methodology
- Enhanced with complementary risk mitigation actions
- Currently available indications: COVID-19 (NEW), Rare Diseases, Healthy Volunteers – Phase 1, Heart Failure, Oncology, Pulmonology, Diabetes, Cardiovascular and Medical Devices
- Fully customizable
- Come standard with MyRBQM® Portal
Try our indication-focused RACT catalogs with MyRBQM® Portal’s free 30-day trial license.