Site Initiation Documentation
The creation, distribution,
and collection of all reg-ulatory documentation relating to site initiation

From the publication of protocols, presentment of the site binder, and distribution of required documents, DRS has the tools and solutions to make this process seam-less to our Pharma clients. For rapid site initiation, milestones are reached expeditiously using DRS’ web-based e-Form portal. All site docu-ments are delivered to the appropriate parties and the return of all signed regulatory documents is accurately measured. The DRS product suite measures and tracks the collection of all 1572, CV, IRB and Financial Disclosure documents.

CRO Training/Management
Training and monitoring of
CRO to promote consist-
ency in essential study document collection

DRS leverages its industry leading document management expertise to ensure consistency in document collection. Our experience also helps eliminate continual CRO follow-up for the collect-ion and tracking of essential study doc-uments which can prove burdensome to all. We then manage this collection and conduct specific training for good document handling prac-tices directly to the CRO on our client’s behalf.

Study File Creation
Electronic and paper Trial
Master File document capture and organization

DRS ClinDoc TMF Services assists clients with the collection of all essential study documents defined in their SOP requirements. This collection can then be completed electronically, on paper or by utilizing a paper/electronic hybrid combination. Good document practices are applied along with clients’ SOPs to have a complete and compliant file.

Unlike many others, DRS ClinDoc services add value by also identifying documents in real time that are not collected in the file. By doing so, investigators visiting the sites will know specifically which documents are captured as well as which documents have yet to be collected.

Through our document WEB submission portal, documents can be uploaded electronically and be ready for present-ment in the repository within minutes.

The subject case book preparation for FDA submission -- including hyper linking, bookmark-ing and redaction -- is also a service DRS provides within its DRS ClinDoc offering.

DRS ClinDoc Software
Works within your existing
platform or as a replace-ment product

DRS leverages 20 years of software development to bring best-in-class document management and pharmaceutical application software solutions to any existing process.

Our products are flexible, component driven pieces that are modular or complete, from document scanning software, web portal for document submission and delivery, electronic signature capture, and many other features.

Our services allow cap-turing documents from
multiple sources, sys-
tems, sites, media and technologies and placing them all in a master elec-
tronic file.

Global Web Repository
Secure and complete access to submission documents via the web

DRS offers its clients a secure, web-based document presentment repository. The repository is designed to limit access to the document via a user ID and password. CROs may view all their documents – while Pharma companies can view the CRO’s plus all other documents. Web presentment enables investigators to share document status with studies around the world securely on multiple forms of media.