The need for each research site to have a documented and comprehensive set of procedures and processes or Standard Operating Procedures [SOPs] is a hot topic in clinical research today.

TPD's¹ inspections demonstrated the lack of these procedures and processes to be one of the most frequent deficiencies at the site level. The FDA² asks to review SOPs when conducting site inspections, and sponsors are more frequently asking to review the site’s SOPs prior to placing new clinical trial contracts with the institution, as a demonstration of the site’s standards of practice.


 
HRC's SOPs

Hegi Research Corp. offers a revolutionary concept in SOPs to clinical research sites. Our 3-part SOP set is compliant to the International Conference on Harmonisation Guidelines for Good Clinical Practice [ICH GCP], Canadian TPD and USA FDA regulations. Each SOP is referenced to applicable regulations, guidelines and other SOPs.

Our leading-edge set of manuals is written in user-friendly language and is designed to function as a training manual or orientation for new staff. Staff are encouraged to reference the applicable regulations, thereby increasing their own knowledge.

Many of the individual SOPs are supplemented by forms, checklists and templates that can be utilised by the site as efficiency tools in the day-to-day responsibilities of clinical research.

The SOPs should be reviewed and approved at the site and reviewed on a yearly basis to ensure continuing compliance. In this way, the SOPs are the basis for an evolving and constantly current set of documents.

HRC was founded in 2001 to offer the services of Independent Clinical Research Consultants to the Pharmaceutical Industry, Contract Research Organisations and Clinical Research sites.


¹ [Canadian Therapeutic Products Directorate]
² [USA Food and Drug Administration]


 
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