Recently, Paragon Solutions attended the annual SCOPE Summit for Clinical Ops Executives in Miami, Florida. There were over 500 attendees at the conference, representing pharma, biotech, CROs, vendors, and clinical site personnel. Jamie O’Keefe, Chris McSpiritt, Michael Agard, Jim Dunleavy and Geoff Lewis represented Paragon Solutions Life Sciences Practice.
On Wednesday, Christopher McSpiritt Chaired a session titled “Improve and Measure Sponsor-CRO-Site Interactions” The session included presentations from Novartis and Bavarian-Nordic GmbH. There was also a panel discussion involving: Adam Chasse from RxTrials; Deborah Manzo from AbbVie; Jamie MacDonald from INC; and Silvana Giustino.
On Thursday, Michael Agard gave a presentation titled “eTMF and Site Activation – how externalization can improve timelines”. Michael described the benefits an eTMF system provides by enabling access to the latest version of a document to end needless searching. An eTMF system can support collaborative authoring and timely tracking of tasks. Dashboards were presented to show the status of the sites ready to receive drug shipment based of completed documents in the eTMF system.
A number of presentations and vendors represented the themes of trial planning, patient recruitment, site selection, site startup. This underscores the importance of getting the rights patients into trials in a timely manner. Of particular interest is the role of social media in connecting people with a particular disease to a relevant clinical trial. The challenge will be to identify new ways to engage both Investigators and patients in the clinical trials. Related to this is the concept of data mining of existing electronic medical/health records to find patients that meet the trial inclusion and exclusion criteria. Lastly, sponsor companies are working to be more transparent with trial data to regulatory agencies, health care providers and patients.
Data and document exchange continues to be a challenge in the clinical trials. Sponsors, partners, CROs and site personnel all need an intuitive platform to collaborate from. Round table discussions around the Transcelerate Portal were heavily attended, with a number of questions posed to the facilitator of the group. Emerging data standards will continue to improve the exchange of information in the conduct of clinical trials. The role of cloud technologies continues to grow, as technology platforms are seen less as a competitive advantage and essential for timely and efficient collaboration. Strategic partnerships and governance between sponsors and CROs are driving business process changes.
Overall, the SCOPE conference organizers did a good job to bring together a number of engaging speakers that covered a number of timely topics pertaining to clinical operations. Getting away from the snow and cold in Philadelphia to Miami was an added benefit.