Page 8 - Assay - Brochure
P. 8


                     The world is surrounded by a variety of
                     technological solutions for every activity
                     occurring on this earth. Clinical Research is
                     no alien to technology. But the need for   GRAVITY
                     advancement continues to exist.

                     Sometimes, the best discoveries         Any data out of a clinical trial will be suitable for analysis
                                                             only when it is organised and preserved appropriately.
                     are the result of simple                However if the process of organising data itself becomes
                     observations.                           tedious, the purpose is lost.

                                                             ASSAY over though many years of experience, has noted
                     ASSAY with its technical team of experts in
                     clinical research and information       that filing system for documents generated at various levels
                     technology together have identified      within a clinical trial is often not given due priority because
                                                             of the overwhelming volume of patient data generated for
                     significant challenges in clinical trial
                     management at various levels.ASSAY has   review. However, in an audit, of all the other findings
                     developed unique software solutions to   related to source documents, a vast majority of findings
                     overcome the day-to-day struggles       (major or minor) still lie within the site files and central files.
                                                             And to top it all, the time and cost involved in creating,
                     facedduring the life of a clinical trial.
                                                             maintaining and implementing CAPA in the filing sector has
                                                             continues to rise as a proportion of costs.

                                                             ASSAY has developed a software system to collectively
                                                             overcome the challenges of document management in
                                                             Clinical Trials and to keep all documents in one place, as
                                                             GRAVITY does.

                       Integrated                 Unique                     Logical
                       FOR EASE OF                USER-FRIENDLY              FILING AND REPORTING
                       DOCUMENT SHARING           DESIGN                     STRUCTURE
                       GRAVITY has changed        Patient specific logs       GRAVITY has been
                       the paper-based            like Patient screening     created based on the
                       Investigator Site File to   log, Patient enrolment    DIA eTMF reference
                       Electronic (eISF) and      and consent log, study     model, keeping in-line
                       integrated it with         specific forms, IMP         with industry
                       Electronic Trial Master    Inventory and              standards and
                       File (eTMF) to enable      accountability logs and    expectations,  making
                       document sharing.          many more have             it most logical for
                                                  become electronic.         document filing.
                       In-built SUSAR             Is'nt that Unique!!
                       management system.                                    Generate exclusive
                                                  Robust desigining of       reports for trend
                                                  our system creates a       analysis.
                       Be sure that the most      user friendly
                       updated documents          enviroment for the
                       are always available to    maintanence of
                       all users.                 documents.

                                                  CRA verification
                                                  functionality enables
                                                  real-time review of
                                                  documents available
                                                  at site-level.

                                                  Electronic signature
                                                  feature enables users
                                                  to acknowedge
                                                  documents in a few
                                                  simple steps.
   3   4   5   6   7   8   9   10   11   12   13