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Are you planning a skin, wound and/or ostomy Clinical Trial or Product Study and seeking qualified study sites?
Wound Care Strategies can save you time using qualified clinical personnel (physicians and clinicians specializing in wound and ostomy care) already positioned for trial oversight. Add our state-of-the-art TriAssess Software and youre well equipped for cost-effective and time-efficient clinical monitoring.
With Wound Care Strategies, you choose.
You have the flexibility to scale our comprehensive services and resources to your exact requirements. Wherever your point of entry, solutions are delivered by highly responsive professionals for a customized package of services based on your particular needs.
Study Design. Use Wound Care Strategies to assist you with pre-study protocol, IRB review, budget preparation and policy and procedure development for the Study. Add the education necessary for the professional staff, subject screening and obtaining consents and you are well on your way to the successful implementation of your Study design.
IRB Proposals. Institutional Review Boards (IRBs) have been established by the federal government to protect the rights and welfare of human subjects participating in research activities. The IRB ensures that physical, psychological, and social risks to research subjects are minimized, and that the risks associated with the research are commensurate with the importance of the research and/or the knowledge to be gained. Wound Care Strategies can assist you in submitting the IRB proposal for your product trial or study.
Training. Clinical staff will be trained in the aspects of the Study. The clinical investigator will focus on the proper use of your product, data collection needed for regulatory submissions, and support for product marketing claims. The training process will ensure correct billing and all cost of care is captured and payment considerations in all sites of service are considered for marketing the product.
Monitoring. Once the staff is trained, the need for excessive on-site monitoring is minimized. Instead, technology for remote monitoring is incorporated. With our TriAssess Software, real-time data capture and continuous monitoring is in place. Decisions concerning Study modifications can be addressed immediately should certain implications arise. This is in contrast to waiting until the completion of the Study for resolve, as evident in a paper process.
TriAssess Software. TriAssess Software is customized for clinical trial or product study for any pharmaceutical or medical device company, contract research organization, university department or governmental / non-governmental organization conducting wound care clinical trials or product studies.
Endpoint Analysis. Once the Study has reached its endpoint and data collected within the TriAssess Software has been synchronized with the central server, compilation of data is instantaneous with reports generally available within seventy-two hours.
Consultations. Off-load tasks to Wound Care Strategies while you increase your knowledge. Our expert strategists consult with you to cover the following:
- Cost of product, or service, and cost of care through review of collected data;
- Payment considerations in all sites of service considered for marketing your product or service;
- R&D, sales, marketing and management consultation regarding various payers for your product or service;
- Any additional areas regarding concerns or implications of the Study or product performance.
For assistance Contact WCS.
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