Clinical Ink

Revolutionizing Clinical Trials

Founded in 2007, Clinical Ink is the pioneering provider of eSource solutions for clinical trials. Developers of SureSource® — the first purpose-built and most widely used eSource plaftform — Clinical Ink is dedicated to streamlining clinical development from Start to Submit™.

Ideal for every phase of clinical development, SureSource makes clinical research easier for sites, sponsors, subjects and regulators. As the only purpose-built solution that meets all regulatory requirements for eSource, SureSource was developed from the beginning to streamline clinical research — by experts in the fields of clinical investigations and medical forms publishing.

Discover how Clinical Ink’s SureSource platform can speed data access to dramatically reduce clinical trial costs and timelines.

Products

Site Experience

Intuitive eSource for Optimal Site Efficiency

An effective eSource solution must be intuitive enough to effectively make clinical research easier. From the beginning, Clinical Ink’s SureSource® platform was designed for optimal site efficiency. Developed and tested with actual site users, SureSource is the only eSource solution designed to actually reduce site workload.

Risk-Based Monitoring

eSource Enabled Risk-Based Monitoring

In the face of increasing clinical trial costs, complexity and regulations, drug makers are under increasing pressure to save money while executing more efficient clinical trials. In an effort to enhance subject protection and clinical trial data quality, the Food and Drug Administration (FDA) issued final industry guidance in August 2013, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring”.

eSource Data Capture

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.

Late Phase Clinical Development

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.

Early Phase Clinical Development

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.