During this challenging and often uncertain time in the world, it is paramount to focus on the things that really matter. Happiness and charity for everyone is crucial always, but especially right now. The practice of all virtues is inspired by charity, which binds everything together in perfect harmony. DSG is and always has been an organization committed to the communities and charities where we live, work and socialize.
Destination - DSG Blogs
At DSG, our commitment to providing excellence in service extends beyond eClinical solutions. This includes giving back to the communities in which we live and work, striving to make a difference each and every day. Corporate responsibility is the platform that best influences how we engage with the clients we serve. Here at DSG, we take pride in the work we do for both our clients and our neighbors. As our company continues to grow, so does the impact we have on the community. Our employees invest their time, talent and resources to help build a brighter future for the communities we serve.
The U.S. FDA has just issued procedural guidance regarding the Use of Electronic Health Record Data in Clinical Investigations. While the guidance is non-binding, it is a clear signal for EDC providers who want to reap the benefits for their customers implementing full eSource capabilities, stating “[t]his guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations…
I regularly visit both sponsor companies and CRO partners and I am often amazed at the lack of knowledge about the functional service provider (FSP) model for eClinical software and clinical data management. Despite the multitude of articles and vendor information on the benefits such a model has for sponsors, many are befuddled as to how this can truly help increase efficiency, reduce error and reduce costs in your next clinical study. Here’s my take.
Practical implications of an FSP
The clinical input needed in the eClinical data systems design-build process and subsequent data management is very limited. This means that splitting a traditional all-in-one CRO contract among two specialized FSPs – one for clinical, and one for eClinical data management (EDC, IRT, eCOA/ePRO, CTMS, and more) does not require sponsors to build a team of FTEs (full-time employees) to manage two versus one contract.
Input from the “owner” of the protocol is useful during start-up. Training monitors on effective use of eClinical systems to make them more efficient in their site visits. That is it. Interaction between the biostatistician ultimately responsible for ...
DSG has experienced large amounts of success by working as a Functional Service Provider (FSP) to sponsors and CROs in need of eClinical software (EDC, IRT, CTMS and more) and clinical data management. If you have not considered the benefits of utilizing an FSP there is no better time than today to consider the advantages over traditional full-service Clinical Research Organization (CRO) models.
FSPs are essential partnerships to the overall success of modern day clinical trials. They provide multiple facets of the clinical trial tasks such as design, medical writing, statistical services, trial recruiting and electronic submission to agencies.
Welcome to our new blog site Destination DSG. The entire team at DSG hopes it will be a place for thought provoking issues surrounding eClinical software and services and clinical data management.
Destination DSG will share industry news, ideas and the latest information from our rapidly growing company. We’ll add personal observations of customer travels, our team across the globe and do so with humor and candor.