Improved Patient Safety And Data Quality
Boston, MA (PRWEB) April 10, 2013
Verified Clinical Trials (VCT) will co-present with SAFE-BioPharma at Bio-IT World April 10th at 4PM in Boston, MA. The session titled “POC Today/ Practical Application Tomorrow: An Inside Look at How Several Companies are Exploring Identity Management in the e-Clinical Trial Space", will focus on innovative proofs of concept for moving clinical trials to fully electronic processes.
Kerri Weingard, ANP, Chief Operating Officer of Verified Clinical Trials and Mollie Shields-Uehling, MA and CEO of SAFE Bio-Pharma Association, will share the way several global companies are utilizing Verified Clinical Trials research subject database and universal identity management protocols (a single cyber-identity recognized by all Sponsors) to improve subject safety, enhance data quality and to maximize use of mobile devices in clinical trials. In a presentation developed in collaboration with Mitchell Efros, MD, President & CEO of Verified Clinical Trials, Kerri will discuss a new capability which leverages the SAFE-BioPharma digital identity and signature standard to provide a mechanism for strong subject identity verification along with the ability to protect those identities for research trial purposes.
This presentation will be held as part of the E-Clinical Trials Solutions, Innovative Management in Clinical Trials track of Bio-IT World. Kerri will be co-presenting with Mollie Shields-Uehling, CEO SAFE-BioPharma, a non profit association which manages the SAFE–BioPharma standard for digital identity and digital signatures used in life science and health care. The session will feature several proof of concepts including the use of tablets to collect patient data in hospital blackout zones, digitally signing ePrescriptions, and managing access to clinical portals. The POCs are designed to decrease study start up time, reduce cost to start up and operation of trial, ensure the security and privacy of subject information and improve safety and data quality.
VCT will issue digital identities based on the SAFE-BioPharma standard for all clinical research site personnel. These personnel may use their SAFE credentials for authentication and signing of documents including signing of 1572, budgets, contract, delegation logs, e-consents, amendments, study protocol signature pages, training modules, and other study related documents. This will result in reduced paperwork, decreased study start up times, decreased cost and assurance of a verified identity.
Clinical trial volunteers will also be verified and obtain SAFE-BioPharma digital identities to ensure true identity. Research subject participants across all studies will be able to issued by a VCT a proxy de-identified digital identity to sign e-consents, e-diaries, and study related information. The research subject participants will be verified to prevent attempted dual enrollment in clinical trials to ensure better quality research subjects enter the trials.
The technologies will also be used to create a map of disease entities by geography and create a research subject self-managed ‘opt-in’ method for pharmaceutical companies to anonymously reach out to subjects directly for study safety updates and for recruitment purposes. In an effort to improve safety, pharmaceutical companies will have the ability to directly reach out to the consenting research subjects that will remain de-identified and anonymous. In this manner, important information regarding the study compound or device such as new safety information, post study safety reporting and creation of on-going registries can be delivered directly to those research subjects wishing to be contacted. Additionally, if so desired, many research subjects will now be able to learn when new clinical trials arise, whether thy received the study medication or placebo, be alerted when the study medication is approved for use and obtain the results of the trial as well by direct anonymous contact by the pharmaceutical company.
About Verified Clinical Trials
Verified Clinical Trials is a forward thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials. Verified Clinical Trials halts dual enrollment in clinical trials and defines itself as the world's leader in the field of database registries in clinical trial research. Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials and has the scalability to reach all sites nationally as well as on a global level. Verified Clinical Trials offers numerous other value added services to the clinical research site, CRO, and Pharmaceutical Sponsor, that prove invaluable with regards to safety, data quality, recruitment, financial and legal compliance and liabilities. For more information, visit http://www.verifiedclinicaltrials.com.
Verified Clinical Trials Contact:
Kerri Weingard ANP Chief Operating Officer
Phone: (516) 998-7499
kweingard(at)verifiedclinicaltrials(dot)com