REMS Information Systems, LLC, specializes in support of the pharmaceutical industry in the design, development, and execution of FDA-mandated REMS programs.
The Company was formed by a group of experienced clinicians, scientists, educators, researchers, regulatory experts, epidemiologists, information specialists, and others dedicated to the safe and optimal use of new drugs in the contemporary marketplace and diverse patient care settings.
Our mission is the support of the pharmaceutical industry in its vigilant and scientifically rigorous approach to promoting and supporting the safe, optimal use of drugs by specifically:
- Developing REMS plans
- Executing various REMS components
- Enhancing effective communication among prescribers, patients, and the FDA
Our experience and capabilities extend across the spectrum of REMS
components:
components:
REMS Timetable and Strategy
Clinical / Legal / Regulatory tactical planning, including advisory boards comprised of respected thought leaders to address clinical, scientific, regulatory, or legal issues around REMS planning and projected use of new drugs.
Medication Guide and Patient Education
Full patient education content development and delivery to patients via multiple channels including hard copy, web, text messaging and e-mail, call centers staffed by specially trained nurses, and automated interactive voice response systems, through which patients can self-monitor for compliance and possible adverse events.
Communication Plan to Health Care Providers
Comprehensive medical teaching capabilities on a customizable, multi-channel communication platform (‘live’ lectures, video, web seminars, enduring CME/CE materials) delivered by experienced and accredited providers of education for health care providers, covering all potential aspects of REMS educational needs.
Elements to Assure Safe Use
Sophisticated trade channel management capabilities that include prescriber training and certification, as well as semi-closed and closed distribution systems
Proprietary, web-based registry and Phase IV study platform that provides services and secure web-based tools to researchers so that they can rapidly and cost effectively execute multi-center studies, using electronic data collection forms that are highly secure and compliant with both HIPAA and FDA’s CFR 11 guidelines.
Implementation System
Integrated REMS assessment and market research capabilities
Ongoing quality assurance and program adjustment as required
The passage of the Food and Drug Administration Amendments Act (FDAAA) in September 2007 directed the FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle. Title IX of the Act, enacted in 2008, included Risk Evaluation and Management Strategies (REMS).
REMS will generally include some combination of the “Elements to Assure Safe Use,” which are:
- Patient education and outreach
- Reminder / Prompting systems
- Performance-Linked Access Systems (PLAS)
- Training and/or special certifications for prescribers and dispensers of the drug
- Restriction of drug dispensed to certain settings.
- Patient monitoring or enrollment in a post-marketing pharmacovigilance registry
REMS Information Systems LLC works with clients and consultants to develop a best-of-breed partnership approach in which the pharmaceutical company has ready access to thought leaders, clinicians and researchers, regulatory experts, and legal authorities. REMS program management using our resources and guidance becomes “turn-key.”