Meet the Winners of the SCOPE 365/TransCelerate Biopharma Solve Challenge
Five winning submissions demonstrate different approaches to using digital protocols to improve clinical study setup. Explore their ideas for reducing manual configuration, strengthening review and validation, and managing protocol changes.
The SCOPE 365/TransCelerate Biopharma Solve challenge received many submissions from teams tackling this shared operational challenge. Thank you to everyone who contributed their expertise, creativity and time, and congratulations to the five winners recognized below.
Watch each winning team’s submission video on the SCOPE 365 YouTube channel to see its approach in action.
Nurocor
Best application of USDM to central laboratory configuration
Nurocor demonstrated how USDM and the Schedule of Activities can support central laboratory setup. Judges highlighted the practical use case, application of standards, validation and connection to downstream execution.
Watch Nurocor’s winning submission →
Saama
Best demonstration of USDM-enabled EDC configuration
Saama connected digital protocol content to downstream configuration, including the use of USDM for Schedule of Activities and codelist content. Judges recognized the structured workflow and its approach to review and validation.
Watch Saama’s winning submission →
ClinMaker
Best integration of standards and amendment impact assessment
ClinMaker combined USDM, ICH M11, CDISC Biomedical Concepts and sponsor standards in its approach. Judges highlighted amendment impact assessment, automated documentation and the generation of test cases.
Watch ClinMaker’s winning submission →
ClinStead
Best demonstration of review and validation before study configuration
ClinStead used a USDM protocol as the starting point and provided a preview before configuration changes were applied. Judges highlighted its arm-by-epoch view for form validation, controls and potential application to downstream systems.
Watch ClinStead’s winning submission →
Intelligent Biopharma / IbGenius
Best demonstration of traceability and role-specific review in study setup
Intelligent Biopharma / IbGenius demonstrated an approach focused on helping different stakeholders review study information. Judges highlighted role-specific data views, inconsistency detection, traceability and SHA validation.
Watch Intelligent Biopharma / IbGenius’s winning submission →
Setting up clinical data acquisition systems often requires teams to read a study protocol, interpret its requirements and manually enter information into multiple applications. Protocol amendments can trigger another round of review and reconfiguration, adding work and creating opportunities for errors.
The challenge asked participants to demonstrate how a digital protocol in USDM format could automate parts of this process, reduce setup time and effort, and improve quality. It also welcomed approaches that improve digital protocol review, traceability, quality checks and amendment impact assessment.
The winning submissions illustrate several ways to address these needs, from laboratory and EDC configuration to standards integration and review before changes are applied.
Our judges brought expertise in clinical data, standards, digital products and study operations to the review process. We’re grateful for the time and care they devoted to evaluating submissions and identifying the distinctive strengths of each winning approach.
Camilla Kehler
Associate Digital Product Director, Novo Nordisk
Gernot Weber, PhD
Senior Director, Head of Data Strategy & Products, Global Functions, Johnson & Johnson Innovative Medicine
Chris Decker
President & CEO, CDISC
Samit Jana
Product Architect, Digital Trial Foundations - Senior Principal Engineer, Eli Lilly and Company
Wafaa Jebert
Global Head of Standards and Data Acquisition, Merck KGaA
Every submission contributed ideas to a practical question facing clinical research teams: how can protocol information move more efficiently and reliably into the systems used to collect study data? We appreciate everyone who took the time to develop and share an approach.
Through Solve, SCOPE 365 and TransCelerate Biopharma bring the clinical research community together to explore solutions to real operational problems. Watch the winning videos and consider what these approaches could make possible for your own teams.