DSMB, IDMC, Adjudication Panels, Post-Market Safety, Outcome Registries.
Independent Data Collection, Administration & Reporting via Electronic Registries/Studies
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Patient and study registries are becoming the norm as companies and products continue to globalize. Registries are also a good business decision for a sponsor company. WATERMARK provides state-of-the-art technology for your registries and the option to submit SAE/SADE information through our post-marketing surveillance program.
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Study Outcome Registries
Study outcomes registries have taken several forms. The latest consensus is that results of clinical trials for marketed products should be posted in accordance with the joint position announced by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) in January 2005. We maintain all study registry information, update as needed, support the servers, and can have many interested parties access the site at one time. Additionally, the study registry can be posted with a link to the patient registry.
Patient Outcome Registries
Patient outcomes registries are a form of post-approval longitudinal studies. The registry is a platform for observational follow-up studies to track groups of interest, evaluate health resource patterns, develop clinical effectiveness and safety hypotheses, detect rates of adverse event reactions, and improve market awareness or products. The patient registry focuses on specific products or procedures, enrolling patients with a specific drug, device, or diagnosis, and following them over time. Registries are essentially a trial with only one arm. Because the registries do not dictate how interventions are used or conditionals treated, unique information from a clinical site is collected with an additional opportunity to study off-label use. By implementing the patient registry, you are monitoring safety in real world settings.
Outcomes Registry Benefits:
There are multiple benefits to implementing a patient registry:
A Marketing Perspective It's the perfect way to engage your customers and discover real-time and actionable insight into how your drug is performing.
A Clinical Perspective It's a unique and powerful method for the collection of observational or epidemiologic data, and is becoming a widely adopted business tool in the pharmaceutical, medical device, biotechnology, academic and private healthcare settings.
A Reimbursement Perspective Medicare and other third party payers use clinical evidence to make determinations about reimbursement.
A Private Provider and Academic Medical Center Perspective It's an effective tool for gathering post-approval research to accelerate innovation, produce faster knowledge gains, and alert companies to potential problems quickly.
Strategic Reasons for a Patient Registry:
- Allows you to collect demographic, observational and treatment data from across many different clinical sites and institutions in real-time, into a centralized, secure, HIPAA compliant database. This database is accessible by the sponsor 24/7, on-demand, and is exportable into Excel, XML, or PDF. - Helps with predicting future revenues and with third-party reimbursement.
- The patient registry is a critical source of information which allows you to identify and remedy product issues pro-actively.
- Provides marketing support by understanding the impact of your drug in the marketplace, understanding impact of your competition, and building a physician community around the product.
- Information on off-label use is collected.
- A registry can provide information on patient population trends and patterns which allows strategic planning by the sponsor company.
- Saves Money! The registry provides information on safety, efficacy, and utilization. Additionally the database is secure, web based, compliant, and archived for 7 years on our high speed servers.
WATERMARK Advantage
WATERMARK specializes in safety oversight of your product from clinical development through post-marketing. We understand the need to monitor safety as well as collect valuable information on the use of your product in real world clinical practice.
The WATERMARK advantage is multifaceted:
Regulatory Experience:
- WATERMARK has extensive experience in product safety.
- We provide independent IDMC, CEC, and adjudication panel oversight or product safety during a clinical trial.
- We support post-marketing safety surveillance for clinical products and can link the registry for reporting.
- We have experience with audits by a variety of regulatory agencies.
Independence:
- The database is supported and maintained independent of the sponsor company. Information can be exported in XML, Excel, or PDF to any database.
- Because of WATERMARK’s background as an independent central data and safety monitoring board, we can provide independent statisticians to help with analysis and creation of tables, listings, and graphs. This independent analysis can help identify trends and can be used in your safety filings with the FDA.
- Because of WATERMARK’s background as an independent central data and safety monitoring board, we can provide independent clinical experts for adjudication of data.
- Because WATERMARK is independent of the sponsor, we can audit clinical sites to ensure the information entered into the database is accurate.
Technology:
- We customize the fields to meet the needs of the clinical, safety, marketing, and sales departments.
- We provide the technology that is easy to use by the physician for input of the patient information.
- We host the site on our secure servers which allow many users access simultaneously. This means there are no access problems by the clinical sites and no maintenance by your IT department.
- Electronic registries provide real time access to critical information needed by the sponsor company.
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