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Independent Safety Oversight, Administration, and Reporting System
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POST MARKETING SAFETY SURVEILLANCE
Our Independent Safety Oversight, Administration & Reporting System for post marketing surveillance is designed to ensure that a product’s safety profile does not significantly differ from the marketing profile granted for approved. Recent safety related product withdrawals, black box warnings, lawsuits and regulatory scrutiny have significantly increased the pressure on pharmaceutical and device companies to track adverse events well into a product’s post-launch life cycle.
The ability of a physician to report safety concerns is important to the FDA. Watermark's approach is to provide an on-line reporting system that gathers critical information for the sponsor, completes an FDA MedWatch form 3500 for the physician if necessary, and is user friendly. We also offer the ability to complete a CIOMS form for international physicians. With this approach, critical information can be collected easily and quickly. The SOAR system can be provided as a link to any registry or data collection for a study to make the reporting process easy for physicians.
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.
- We have provided support to sponsor companies for audits by a variety of regulatory agencies.
Independence:
- The database is supported and maintained independently of the sponsor company.
- Information can be exported in XML, Excel, or PDF to any database.
- Due to 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.
- WATERMARK can provide clinical experts for adjudication of data who are completely independent of the sponsor.
- WATERMARK can independently 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.
- The safety surveillance database provides real time access to critical information needed by the sponsor company.
To Learn more about the WATERMARK Approach, Click Here.
To Learn more about the WATERMARK Process, Click Here.
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