PROFILE
R.A.P.T.A.R® Reporting assists clients with the Rapid, Automated, Processing and Tracking of Adverse Reactions for both clinical and post-marketing drug safety.
Ease of use
- Linear Form Process
- Dynamic reporter journey
- MedDRA Patient Friendly & HCP Terms & definitions
- Limited free text fields
- No account required to complete
- Nonsense Checks throughout
- Ability to upload lab results; literature articles; pictures and a variety of supportive document assessments
Convenience
- Seamless QR Code - Website link access
- Variety of adverse reaction reports available
- Pregnancy Form and baby ADR form built in
- Built with ICH E2B Fields
- 24/7 access
- Specialised units/fields for Devices/In-Vitro Devices, Vaccines, Veterinary, Advanced Therapies and Clinical Trials
Output
- Capture of Adverse Reaction, Patient, Reports and Product information
- Paternal and maternal pregnancy exposure, including access to baby ADR form
- Required Fields, Causality, Seriousness, Automatic Follow-up throughout
- Configurable frequency of follow-up and timescales - Including long-term
- Analytics
- Case Closure - Expedited E2B XML R3, PDF Report
Built by Pharma, for Pharma
- Designed with 150+ years of combined Global PV experience
- Suggestions influenced by highly experienced personnel
- Multi-sprint user testing and internal audit performed
- User journey confirmed by both industry professionals and general public
- Configurable application, tailored to specific demands of client and product
MISSION
The need for improved reporting of adverse reactions, for both clinical and postmarketing, has never been greater!
- Case processing increasing year-on-year;
- Cost of recruitment and training on the rise in order to maintain timely reporting and accuracy;
- Human error being amongst leading regulatory inspection findings, which may occur from partners completing paper forms;
- Lack of timely and consistent follow-up as may occur from partners/investigators or direct reports;
- Late case submissions continuing to be reported due to lack of timely follow up by partners/investigators;
- Number of emerging markets increasing with additional requirements for reporting;
- Surge in demand for reporting adverse reactions from Health Care Professionals and Patients/Consumers;
- Dramatically reduce the time for processing adverse event cases;
- Increase the Quality and completeness of the reports to aid causality determinations and signal identification
SOLUTION
The need for improved reporting of adverse reactions, for both clinical and post-marketing, has never been greater!
DEVELOPMENT
Developed in collaboration with ranked #1 software developer in the UK and both GDPR and 21 CFR Part 11 compliant; built with GAMP validation criteria in mind, R.A.P.T.A.R® uses the latest MedDRA version for Adverse Event (AE) capture and patient friendly MedDRA terms to help facilitate both Healthcare Professionals (HCP) and the general public with reporting Adverse Drug Reactions/Events/Undesirable Effects and Adverse Incidents (ADRs/ AEs/UEs/AIs) and Serious Adverse Events (SAE), for medicinal; cosmetic; veterinary and nutritional products; medical devices; vaccines, and advanced therapy medications using standardised data capture fields for the relevant product types.
The report also captures pregnancy exposure data and patient laboratory data, with in-built normal ranges (R.A.P.T.A.R® Clinical), and allows upload and attachment for items such as medical data forms, test results and more.
Additionally, R.A.P.T.A.R® will utilise automatic follow-up and nonsense datachecks to create and electronically submit an accurate, valid report directly to the client’s safety database, in compliance with ICH E2B R3 data fields, with full and extensive analytic features; accessible via the client’s bespoke portal to monitor case volumes, processing times, follow up status.