Symfo International And Isis Innovation Announce A Unique Turnkey Solution For Patient Reported Outcomes (PRO) Operations
Isis Outcomes, a part of Isis Innovation Ltd, and Symfo are applying their respective areas of expertise to offer Sponsors and CRO1s a unique service that will help Drug Development/Study Managers to assess and choose the right PRO2 measure – validating and deploying PRO instruments, and ensuring that the study will meet Regulatory Authorities requirements.
PROs are increasingly used during the drug and medical device development process to prove effectiveness; most Primary and Secondary endpoints in clinical trials use PRO instruments to measure efficacy. PROs are also used in health policy decision-making processes when comparing treatments. Their accrued importance is such that the US FDA issued Guidance for Industry on the Use of PROs in December 2009.
After a PRO has been designed, tested and validated it must be deployed correctly to collect the required information. Traditionally, PROs have been completed and collected on paper but there is a growing trend to use electronic systems (called ePRO) to collect better and more reliable data.
Now, using ePRO technology, Symfo and Isis Outcomes deliver the whole PRO cycle.
Initially a concept evaluation is performed with the Sponsor. Once the targeted endpoints are identified a suitable PRO will be selected, or, if required, a new PRO will be developed or modified in accordance with international regulatory guidelines. The instruments - and translations, if required - will be validated. The PRO will then be migrated, with appropriate checks to ensure equivalence, to the selected electronic platform. Symfo and Isis Outcomes provide assistance to select the most appropriate e-platform for a trial. The resulting ePRO will be deployed in the selected countries and languages, and data will be collected. Symfo and Isis Outcomes will collate the data, and can perform analysis and assist with submission to Regulatory Authorities.
References:
1CRO: Contract Research Organisation, or sometimes Clinical Research Organisation.
2PRO: ‘a measurement based on a report that comes directly from the patient about the status of a patient's health condition…', (source: FDA). PROs are used to measure treatment benefits or risks in medical product clinical trials. Some treatment effects are only known to the patient. The most understandable example is pain, where only the patient can tell us about the intensity of his/her pain.
About Symfo
Symfo, a privately owned, global electronic patient reported outcomes (ePRO) provider, specializes in creating patient-oriented, cost effective, robust and reliable ePRO and data collection solutions for CROs, pharmaceutical, biotech, medical device companies and academic institutions conducting Phase I to IV clinical studies or post-marketing surveys. Our solutions include a variety of ePRO technologies to suit every client's needs, allowing us to offer everything from « full-service » to « technology transfer ». Symfo has developed high-value, cost effective ePRO solutions for clients both large and small in numerous clinical and post-marketing studies.
Symfo's unique data transmission technology has proven that reliability and simplicity does produce results and delivers a technology platform that can be used in any therapeutic area and in any part of the world. Symfo has been delivering ePRO solutions since 2000. It has offices located in Boston, MA and in Luxembourg. For more information, visit www.symfo.com
About Isis Innovation and Isis Outcomes
Isis Outcomes is an activity within Technology Transfer at Isis Innovation Ltd, dedicated to the provision and support of the highest quality PROs for healthcare providers and the pharmaceutical industry. It manages a large library of over 100 translated versions of the Oxford PROs, commissions user support materials, such as manuals, and arranges consultancy advice to customers from PRO experts in Oxford. Isis Innovation is the University of Oxford's technology transfer company and manages the University's intellectual property portfolio, working with University researchers on identifying, protecting and marketing technologies through licensing, spin-out company formation and material sales. Isis files on average one new patent application each week, has concluded over 500 technology licensing agreements, and established 70 new spin-out companies from Oxford since 1997.
Isis also manages Oxford University Consulting, which arranges consulting services providing clients access to the world-class expertise of the University's academics to enhance innovative capability. Last year OUC arranged over 150 consulting deals. A separate business division, Isis Enterprise, provides consulting expertise and advice in technology transfer and open innovation to university, government and industrial clients around the world. Isis was founded in 1987 and is today one of the world's leading technology transfer and innovation management companies. For more information, visit www.isis-innovation.com.
SOURCE: Isis Innovation Ltd