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Clinical Ink

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eSource: Reducing Site Workload for Better, Faster, Safer Clinical Trials

More sponsors and CROs are looking for new ways to better leverage investigative site relationships to improve clinical trial performance. To this end, some clinical organizations have adopted electronic source (eSource) to help improve study quality and efficiency - for both sponsor and site. Unlike traditional electronic data capture (EDC), SureSource, Clinical Ink’s eSource platform, was designed from the beginning to minimize clinical trial complexity for site users. As SureSource adoption increased, study teams began to see an improvement in data quality, operational efficiency and ease of use compared to traditional methods (paper and EDC). A Site Impact Survey provides scientific evidence regarding the impact of SureSource from 517 site users. Results confirm it significantly reduces workload, lessens queries, and improves data quality compared to paper and EDC. In this white paper, we quantitatively evaluate survey outcomes, provide qualitative feedback from survey respondents, and highlight the observed benefits of SureSource for transforming clinical research.
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News and Press Releases

PCI Pharma Services Announces Bottling Line Expansion to Support Customer Needs

Philadelphia, USA – February 5, 2019 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, is pleased to announce the expansion of its bottling line capacity at its Commercial Packaging site in Rockford, IL. Construction of the additional packaging suites began in March 2018 to add considerable footprint for primary and secondary packaging operations equipped with high speed tablet filling, cartoning, as well as in-line serialization and aggregation in support of increased customer demand. The new expansion will grow the robust bottling operation in Rockford by producing an extra 100 million bottles per year.
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White Papers

The Process of Informed Consent (written by ACRP)

CenterWatch

Every investigator and clinical research coordinator (CRC) should recognize the importance of obtaining valid and appropriate informed consent as an important protection of the rights and welfare of human subjects. The purpose of this ACRP guidance document is not to provide a literature review or summarize the recommendations of various working groups. Instead, the Association decided it would be helpful to provide short and focused guidance which describes how to best structure the informed consent process in accordance with best practices.
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Industry Events

PDA Europe Annual Meeting 2019

24 June 2019, Hilton Amsterdam

Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
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