Welcome & IntroductionParam SinghVice President ofClinical Trial Management Solutions• 10+ years of experienceimplementing Siebel Clinical• Managed over a dozen Siebel Clinicalimplementations
Today’s AgendaTime Topic2:00-2:05 Welcome and Introduction2:05-2:10 Benefits of CTMS-EDMS Integration2:10-2:20 3 Approaches to EDMS Integration• Mock• EDMS-Driven• CTMS-Driven2:20-2:45 Live Demo of 3 Approaches2:45-3:00 Q&A
Benefits of EDMS Integration• Streamlines document trackingprocess• Reduces data entry error• Saves time• Eliminates need to search EDMSfor a document• Simplifies audits
Mock ApproachWhat It Does• Auto-generates a hyperlink in CTMSto the expected location of thedocument in EDMS, based on thefolder structure in CTMS• Not a true integration; nocommunication between CTMS andEDMS
Mock ApproachHow It Works1. Create document tracking record in CTMS.2. URL field auto-generates hyperlinkconsisting of base URL (such aswww.documentum.com) PLUSprotocol/site location in CTMS.3. Example:http://sharepoint.biopharm.com/CTMS/Prot_x123/Site101Note: Requires same folder structure in EDMS as CTMS
Mock ApproachPros• Inexpensive and quick to implement– Add code behind one fieldCons• Less precise– Points to folder, not document• Populates as soon as record iscreated in CTMS– Cannot tell whether document has trulybeen uploaded to EDMS
EDMS-Driven ApproachWhat It Does• Auto-generates a hyperlink in CTMSwhen the document is uploaded intoEDMS• Can also share metadata about thedocument
EDMS-Driven ApproachHow It Works1. Document tracking record is createdin CTMS, and includes a document“code.”2. Document is uploaded to EDMS andrequired metadata is entered,including document code.3. Interface finds corresponding recordin CTMS and populates URL fieldwith link to document in EDMS.
EDMS-Driven ApproachPros• Links directly to the document• Easy to see which documents have /have not been uploaded to EDMS• Can share document metadata inboth directionsCons• Requires document tracking record toexist in CTMS ahead of time
CTMS-Driven ApproachWhat It Does• Through CTMS, auto-creates adocument record in CTMS and EDMS• Auto-populates a link in CTMS torecord in EDMS• Can also share metadata about thedocument
CTMS-Driven ApproachHow It Works1. Upload document to CTMS asattachment and enter requiredmetadata.2. Click [SendFile] button.– Creates corresponding record in EDMS– Creates corresponding documenttracking record in CTMS with link torecord in EDMS3. Maintain document in EDMS.
CTMS-Driven ApproachPros• Creates all document recordssimultaneously• Hyperlink always points to samelocation in EDMS, so always links tomost current versionCons• Original version of document alwaysavailable in CTMS, which could be acompliance risk