ELECTRONIC TRIAL MASTER FILE (ETMF) MARKET ANALYSIS

Market Concentration and Competitive Landscape

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Growing need for regulatory compliance and data integrity

Managing clinical trials in adherence to rigorous regulatory standards and maintaining highest level of data integrity is crucial in drug development process. Documents could be misplaced, data transcription errors might occur while transferring information between paper to systems. Regulatory audits involving huge volumes of paper files are challenging and delays in document retrieval impacted audit outcomes. With globalization of clinical trials, demonstrating compliance to authorities across country-specific regulations was challenging with paperwork.

Life sciences industry is under constant watch by regulatory bodies worldwide to act responsibly and demonstrate highest ethical practices. Even a minor deviation from set protocols or loss of essential documents can severely hamper development programs or invite penalties. In this stringent regulatory environment, leveraging advanced technologies like eTMF has become imperative to ensure compliance and data integrity. eTMF facilitates automatic version control, audit trails and signatures, thus, helping track any changes made to data over time by user. All document access and modifications are tightly controlled, recorded and attributed to specific users. This offers complete transparency during regulatory reviews and audits.