Icertis, a provider of enterprise contract management in the cloud, has announced an upgrade to the Icertis Clinical Trial Agreement and Budgeting solution designed to improve clinical trials contract management. Built on the Icertis Contract Management (ICM) platform, the solution speeds up clinical trial contracting while improving collaboration and compliance with CRO.

“The pharmaceutical industry is under intense pressure to navigate compliance requirements and balance them with fast-moving innovation—efforts that can often be diametrically opposed,” said Nagi Prabhu, chief product officer at Icertis. “Clinical trial environments are inherently complex, and have been full of very manual, disparate processes. This upgrade further improves the ability to manage contracts and all associated processes for clinical trials. Customers will realize measurable benefits in reducing contract timelines and unifying efforts across their network of partners and global locations.”

One global pharmaceutical company who has deployed ICM and the Clinical Trial Agreement and Budgeting solution saved $75 million annually and reduced contract cycle times for its clinical trials by 80%, automating a manual process that previously took up to 75 days to complete.

According to research compiled by the Association of Clinical Research Professionals, each day a trial delays a drug’s time to market costs sponsors between $600,000 and $8 million. Contract and budget negotiations and approvals are responsible for 49% of study delays.

ICM helps customers in this highly regulated industry by providing an easy, intelligent and enterprise-wide solution that consolidates the contract lifecycle workflow. When used with the Clinical Trial Agreement and Budgeting solution, ICM allows for greater efficiencies in the tracking of trials and increases visibility into financial performance. As a result, companies can effectively mitigate costly clinical trial delays and improve time to market for new drugs.

Key capabilities of the Icertis Clinical Trial Agreement and Budgeting solution include:

• Trial agreement clause language and templates with multi-lingual support for global operations
• Intelligent authoring, workflow and compliance processes to ensure effective clinical trial agreements
• Fair Market Value (FMV) validation and tracking
• Trial budget management including standard cost maintenance, budget formation and finalization, budget consumption tracking and budget history/audit tracking
• Trial milestone and payment management
• Site management with on-boarding and approval process, compliance documents and self-service enablement for sites
• Collaboration portal to enable agreements and budgets creation and management with CROs
• Insights and reporting on site contracting history, customized spend analysis, compensation tracking per study, and obligation reporting