Shannon Roznoski
Director, Product Management, Forte

Last week, I had the opportunity to attend the Society for Clinical Data Management (SCDM) Annual Conference in Baltimore. I was excited to see the growth of the clinical data management domain, which was echoed in the various presentations at the conference.

Throughout the conference, some consistent themes emerged, including:

• The transformation of clinical data management into clinical data science
• Embracing how data management, monitoring, and biostatistics are merging and overlapping to create a new discipline focused more on the intelligent management of data via risk-based approaches
• Technology-enabled trends and outlier analysis
• Connected technology systems and their impact on the clinical trial landscape

The push to integrate systems and perform automated analyses on data is increasing the pressure to adopt standards-based frameworks for exchanging data and metadata. I believe we have reached the tipping point where eSource is moving from single-use point-to-point solutions toward a broader framework, enabling the standards-based exchange of data with little variation at the site level.

There are several groups within the clinical research industry working towards this vision of standards-based data exchange, many of which presented on their experiences at the conference:

• TransCelerate Biopharma recently completed a project to map HL7 standards to CDASH for Lab Domain to enable more seamless use of electronic health record (EHR) data in clinical trials. Aruna Vattikola, Business Technology Services, Global Development Operations, Novartis Pharmaceuticals, representing TransCelerate, provided an update on this project.
• Teri Grieb, PhD, Senior Director for Research at the University of Michigan Medical School, presented a different take on data exchange. Teri shared the results of a pilot to improve transparency and reduce study start-up timelines by sharing interactive dashboards sourced from their site CTMS with key sponsors. These dashboards allowed for open dialogue on how to improve efficiency together.
• Michael Buckley, Manager, CRIT Enterprise Innovation at Memorial Sloan Kettering Cancer Center, shared the MSK strategy for implementation of eSource and provided detailed results of a recent pilot for the exchange of lab data with sponsors. Michael is also a co-chair of the SCDM eSource Implementation Consortium.

The SCDM eSource Implementation Consortium is a network bringing together academia and biopharmaceutical companies, along with EHR vendors, EDC vendors and technology providers, establishing methods of clinical trial data transfer, define best practices that can be scaled up across the clinical research enterprise, and consistently share progress with the FDA Center for Drug Evaluation and Research (CDER) Health Information Technology (IT) Board, and other regulatory authorities. The consortium is dedicated to enabling the faster and more efficient digital exchange of clinical research source data from academic medical sites to industry sponsors.

Forte is the first technology provider to join SCDM’s eSource Implementation Consortium, demonstrating its commitment to fostering collaboration between sites, sponsors and vendors to promote greater efficiencies and improved research outcomes. The SCDM eSource Implementation Consortium is now open to new members. If you are in the biopharmaceutical, technology or academic spaces, this is your opportunity to have a seat at the table in these important discussions and to help drive the transformation of clinical data management through developing eSource implementation best practices and standards. You can learn more about joining the consortium on the SCDM website.

Forte’s commitment to eSource initiatives extends beyond its membership in the consortium. Forte is pleased to announce Forte EDC 9.0, which includes a lab results interface allowing organizations to pull lab data from a source system into eCRFs using SMART on FHIR. The lab integration between EHR systems and Forte EDC allows research institutions to gain efficiency in their investigator-initiated trials (IITs) today, paving the way for further efficiency across the industry by providing the foundation for site and sponsor integration. Additionally, research institutions looking to interface their instance of Forte EDC with their Epic EMR System are able to take advantage of Epic’s new USCDI on FHIR program, allowing sites to use FHIR-based interfaces to connect directly with Epic.

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