Periapproval Services
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Registry Services
Covance Periapproval Services brings close to twenty-five years of experience in observational and outcome programs in virtually every therapeutic area. We offer a full range of registry services to pharmaceutical, biotech, device and medical society clients. Registries can assess clinical, economic, quality of life and satisfaction outcomes, document patterns of care and confirm safety profiles for patients who are treated with a specific product, procedure or have a specific condition. Registries offer a cost-effective, observational alternative to traditional clinical programs.
Customers come to Covance Periapproval Services in various stages of readiness to begin a registry. Our experienced medical, epidemiological and statistical staff can work with you to identify key research questions, design a protocol, establish and define key data elements and create data collection forms. Covance Periapproval Services can also create participant manuals, draft template patient consent forms, develop site-training materials to help registry participants recruit patients and complete forms according to the protocol.
We offer the flexibility of supporting your program with a proprietary, customizable data collection tool or collecting data via other industry or sponsor tools.
Covance Periapproval Services can help recruit, register and train registry participants and provide ongoing user support, through toll-free helplines, group training sessions, training DVDs , CD-ROMS or videos and on-line help files.
Many clinical trials, involving life saving treatments or products, often utilize Phase IIIb programs in their protocols and continuing clinical research development plans. These programs transition patients from clinical development to marketplace introduction.
Phase IIIb studies are run under an IND, and typically begin shortly before regulatory submission and are completed prior to the product launch. The objective is to provide treatment of life saving products after involvement in a clinical trial until the marketed product can be obtained. They can also develop data for the indication in the submission to support marketing launch claims, develop information on use in special patient populations that may not have been well studies in the NDA, strengthen the safety profile by expanding the number of patients treated and length of treatment.
Studies may be highly structured like a standard Phase III design or a more simplified trial design with a larger study database. The data must be summarized at the time of regulatory submission and can be used for publication when complete. In some cases, results have been used to develop additional product claims in the label.
Covance Periapproval Services offers all the supporting expertise, resources and services to support Phase IIIb studies. |
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