MALVERN, Pa. — DSG, a leader in electronic data capture (EDC), has teamed up with Canada’s leading licensed producers of medical grade marijuana, Bedrocan Canada Inc. and Tweed Inc., subsidiaries of Tweed Marijuana Inc., to provide EDC and Electronic Patient Reported Outcomes (ePRO) services for the companies’ current large-scale in-country clinical study, the largest of its kind.
The primary objective of the study, which is intended to continue for three years, include more than 50 sites, and enroll up to 6,000 patients, is to evaluate the quality of life (QoL) of patients before and after treatment with medical cannabis.
eCaseLink significantly increases clinical trial management speed while reducing study management cost. A truly integrated solution, DSG’s eCaseLink seamlessly combines EDC, ePRO, Risk-Based Monitoring, eSource, IWRS Randomization-Clinical Supply, Drug Safety, Site Payments and CTMS into a single harmonized system.
DSG’s clinical study build tool makes initial EDC startup intuitive and fast, with unparalleled support services and hands-on training for self-build studies, used also by DSG’s team in providing full service SaaS software systems.
eCaseLink.Me, DSG’s Web-based ePRO solution allows study participants to sign in to a study portal and self-register into the study, providing an email address, demographic and indication information, using their own Web-connected devices with over 150 separate questions for participants and Center professionals.
Participants are then assigned to a clinic where they visit, providing their email address which becomes their system USER ID.
Patient selects Indication only once in the study and either English or French language via a dropdown. Enrollment is done by the Center through a screen (temporary site) where personnel pull in the registration information and provide the login information to the participant. The system emails a temporary password which the participant must use it to log in and change it.
Participants find DSG’s eCaseLink.Me very friendly and easy to use with backgrounds participants may “customize” which promotes compliance. If a participant has not entered data by a pre-determined time each day, an auto-email reminder is sent to the Center, to the CRA and also to Tweed personnel. Questionnaire data resides within eCaseLink EDC database, viewed only by Center, Tweed, etc., where data is extracted by Tweed via friendly reporting tools and on-demand SAS exporting. No revisions to data are allowed. Date and time of entry automatically logged by system – patient is unable to enter this date.
“We are excited to play a critical role in this unprecedented quality of life study in the growing medical marijuana field,” said Tony Varano, CEO of DSG, Inc. “DSG is very confident in the successful conduct of this clinical trial and looks forward to contributing to high quality data collection which may lead to life-changing prescriptions in Canada and the world.”
Bedrocan Canada is focused on clinical research, technologically-advanced, automated production processes, innovative product development, and environmentally responsible production and operation. The Company produces six strains of medical cannabis, and has two facilities in the Greater Toronto Area licensed by Health Canada under the Marihuana for Medical Purposes Regulations. Bedrocan Canada and its licensor Bedrocan Beheer BV (Netherlands) are the only companies in the world currently capable of producing standardized full-bud, pharmaceutical-grade medicinal cannabis.
About Tweed Marijuana Inc.
Tweed Marijuana Inc. is Canada’s first publicly traded medical marijuana company and the first geographically diversified producer with a total of four licenses under the Marihuana for Medical Purposes Regulations. Through its wholly owned subsidiaries, Tweed, Tweed Farms, and Bedrocan Canada, the Company operates three state-of-the-art production facilities in Ontario, and distributes marijuana across the country to Canadian patients managing a host of medical conditions. The Company is dedicated to educating healthcare practitioners, providing consistent access to high quality medication, and furthering the public’s understanding of how marijuana is used for medical purposes.
DSG, Inc. supports clinical data capture and management with a proprietary, organically integrated suite of award-winning user-friendly technology solutions, including flagship eCaseLink™ EDC, Risk-Based Monitoring, eSource, ePRO, IWRS Randomization-Clinical Supply Systems, Drug Safety System, and CTMS. Since 1992, DSG has successfully supported thousands of clinical trials for over 400 companies and 25,000 sites across 93 countries, headquartered in Malvern, Pa., with additional offices in the U.S. and Asia: www.dsg-us.com.
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Jack Minster, +1 484-913-2112