In an effort to streamline and modernize clinical investigations, the U.S. Food and Drug Administration (FDA) in September 2013 issued final guidance on Electronic Source Data in Clinical Investigations. In this guidance, the agency promotes capturing source data in electronic form to assist in ensuring the reliability, quality, integrity and traceability of data from electronic source to electronic regulatory submission.
Well-conducted Phase II clinical trials provide the data required to determine if there’s a case to be made for progressing a drug candidate into Phase III trials. However, Phase II success rates are lower than at any other phase of development. These larger late phase studies present unique challenges and even greater opportunities for the use of eSource to reduce costs and timelines.
The goal of early-phase clinical development – Phase I through IIa – is to test for the safety and efficacy of a drug candidate. In any disease state, conducting successful early phase trials is a key component of ushering a novel therapy through clinical development. Clinical Ink’s integrated SureSource® platform streamlines clinical development – from start to submit — to dramatically reduce R&D costs and project timelines while improving data quality and patient safety.