This DIA 2017 presentation by Dr. Jules Mitchel provides an overview of paperless clinical trials and the tangible benefits that electonic source data (eSource) provides to Sites, Patients, Sponsors, and Regulators.
Now that paper records are disappearing from the clinical trial landscape, functionalities of the clinical trial enterprise should be easily available at one website and with one login. While documents can sit in the trial master file (TMF), access to the EDC system should be seamless from the time that the patient electronically signs the informed consent form (eICF).
Target CTMS™ is a secure, USER FRIENDLY, web-based clinical trial management system (CTMS) which enables users, depending on their roles and responsibilities to manage a clinical trial, all within a web browser and without installing any software.
Target Document® is a secure, USER FRIENDLY, 21 CFR Part 11 complaint, web-based document distribution and management system which enables users, depending on their roles and responsibilities to post, share, electronically sign, and archive any electronic document, all within a web browser and without installing any software.
The Target Encoder is a secure, USER FRIENDLY, Web-based, coding tool that makes auto and manual encoding of adverse events and medications terms obtained from Case Report Forms (CRFs) to standardized MedDRA, and WHO Drug Dictionary (WHO-DD) terms faster and easier.
The economic impact of using a paperless trial master file (TMF or eTMF) in a 80-center study in ulcerative colitis.
eClinical Forum, Jules Mitchel, October 2014
The Society for Clinical Research Sites (SCRS) is pleased to recognize and welcome Target Health, Inc., an industry leading full service eCRO, as a new Site Development Partner.
Target Health Inc., and TechnoSTAT Ltd., are pleased to announce a strategic collaboration to provide high quality and competitively priced 21 CRF Part 11 compliant electronic data capture (EDC) and paperless clinical trial solutions to Israeli life science companies.
Newest version of the company’s Internet-based Document Management and Document Sharing Software.
Target Health was Protalix’s CRO partner and together with Cato Israel, who monitored outside of North America, we took this product from toxicology to the pre-IND meeting, IND submission, Phase I, Phase III, Orphan Drug, Fast Track, Expanded Access, multiple FDA meetings and now the eCTD NDA submission.
Robust Document Management Solution for Clinical Trials.
Target Health, Inc is one of thirty-five leading organizations from the clinical research community have pledged support for new initiative.
According to Target Health’s President, Dr. Jules T. Mitchel, “Target e*CRF Version 1.7 was developed in close partnership with one of Target Health’s premier clients, and is based on input from all areas of the clinical trial process, including trials management, data management, and biostatistics.”
Target Health, Inc. is one of the twenty-seven leading organizations from the clinical research community have already pledged support.
Newest version of the company’s Internet-based Document Management and Document Sharing software.
To optimize clinical development, WellSpring turned to Target Health to provide an Internet-based electronic case report form (CRF) without having to supply software to each study site. There was immediate cost savings of 30 percent from a paper trial.
In addition to new efficiencies, Internet based clinical trials introduce new responsibilities for clinical research teams and investigators alike.
One of the most difficult parts of implementing Internet-based Clinical Trials, has nothing to do with the fundamental technology, but rather with making the necessary changes in structure, mind-set and culture within the sponsoring company as well as the clinical study sites. Choosing the right people to manage and execute the process is key to the success of any program.
By reducing data entry errors through the use of online edit and logic checks in clinical trials, there is improved data quality as well as a reduction in the time to database lock.