Pharmaceutical Research & Development
Fast technological change and increased regulatory scrutiny run hand in hand to make pharmaceutical research and development one of the most difficult challenges to any life science company.
This has resulted in a large increase in the number of pre-clinical and clinical studies as well as an increase in the amount of content that must be managed to support a new product submission. As a result, the R&D operations of life sciences companies are under increasing pressure to ensure efficient creation and management of R&D content.
DCS have developed solutions to automate the entire content lifecycle of this information from early research and development (R&D) through eSubmission. By automating the creation, processing, and management of business-critical content, DCS Solution for Life Sciences improves the productivity of R&D efforts, reduces product development costs, and accelerates time to market for new products.
Key requirements for R&D content management include:
Manage protocols, methods, tests, and images – R&D content including procedures and processes (for example, protocols, studies, and tests methods as well as raw data such as images and data sets) need to be managed in an efficient and regulatory-compliant environment.
Administer studies, collaborate with research partners – As life sciences organisations increase their reliance on joint ventures and external research partners (such as contract research organisations), much of their knowledge and ensuing content is created and stored externally.
Gather and share R&D knowledge globally – R&D information comes in a variety of content types and formats. Rapid and seamless access to this information is needed to transform the content into knowledge.
Author, approve, and publish regulatory submissions – The efficient management and publication of submission content is a requirement – not an option – in the life sciences enterprise. A missed paperwork deadline can mean a six-month delay in the approval process and impede a product’s time to market.
Solutions which address the above requirements:
FileStore document and content management
FileStore is a suite of document, content management and business automation products which enable your organisation to create, manage, approve, review and finally publish via eSubmission a coordinated set of pharmaceutical product information.
Full auditing, lifecycle management and team workflow business processes can be implemented to comply with existing submission procedures.
Alchemy document archiving solution
Alchemy is a low cost and easy to use solution for the bulk archive of any electronic or scanned information such as CRFs, Research notes, Lab books, etc.
Document scanning services
provide a full outsource service (on or off-site) to securely handle the scanning and digital production of trials paperwork. Our scanners can handle anything from lab notebooks, CRFs, X-Rays, Lab charts and microfilms bringing them together into a single set of fully indexed and book marked PDF files ready for submission of archive.
If you would like to discuss with one of our consultants how we can improve your R+D information management then please contact DCS.
Whitepaper documents:
Electronic submissions: Applying cutting edge technology to the regulatory process [PDF 147KB] Using the web to manage clinical trials [PDF 204KB]
