The Challenges of Clinical Document and Data Exchange
Life sciences organizations frequently partner with CROs to develop products. They also partner to license or acquire products through mergers and acquisitions. Throughout these partnership activities, sponsors exchange large amounts of documents and data and need quick access to them.
The unstructured nature, the scale, and the use of different standards by different partners make the process of exchanging content and data extremely challenging. Manual review processes are slow and prone to error. In the case of CRO content, delays in getting study information into the trial master file can directly impact inspection readiness.
The combination of increasing costs, continuing delays, and substantial risks to compliance have raised this issue as a priority for organizations that view clinical intake as a strategic imperative.
NNIT's Clinical Intake Solution
NNIT’s clinical and technology experts have developed a solution that combines automation, artificial intelligence (AI), and analytics to enable efficient and compliant partner collaboration and document exchange.
- Automation scales manual document exchange (intake and export) processes.
- AI and large language machine learning models augment SME knowledge and facilitate the consolidation of standards across large document collections.
- Analytics and reporting enable teams to track issues, understand their origin, predict future issues, and implement corrective and preventive measures.
NNIT's Clinical Intake Solution offers flexible and scalable capabilities to automate the identification, classification, and enrichment of partner data and content. The solution supports bulk eTMF intake and export to address the collaboration needs of:
- CRO to sponsor content transfers
- Development partner activities
- M&A and divestitures
A Robust Solution Built on Mature Technologies
- Maintain inspection readiness by efficiently funneling external documents into internal standards, correcting metadata, identifying, and augmenting missing data, and automating completeness checks
- Improve oversight with data-driven, enterprise-scale dashboards and analytics that facilitate understanding of CRO activities and issues, and drive decision-making and risk mitigation efforts
- Increase efficiency and compliance by standardizing and automating data and document exchange processes that reduce the use of incomplete or incorrect data and the effort required to exchange documents throughout the organization
- Support M&A activities with efficient and accurate TMF exports and imports
Contact the NNIT team to learn how you can take advantage of Clinical Intake to increase efficiency, compliance, and data quality.