Standard Operating Procedures
ClinCoach offers 20 Standard Operating Procedures for clinical research sites. Currently these are the only SOPs worldwide, which are international and incorporate the following regulations and guidelines:
- International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines
- International Conference on Harmonisation (ICH) Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
- Health Canada Therapeutic Products Directorate Food and Drug Regulations for Clinical Trials. Division 5. Canada Gazette Part II, Vol. 135, No. 13, June 7, 2001
- USA Food and Drug Administration FDA Code of Federal Regulations, 21 CFR.
- Tri-Council Policy Statement; Ethical Conduct for Research Involving Humans; Medical Research Council of Canada; Natural Sciences and Engineering Council of Canada; Social Sciences and Humanities Research Council of Canada, August 1998.
- Personal Information Protection and Electronic Documents Act (PIPEDA) Privacy Law in Canada
The ClinCoach SOPs have been written as a comprehensive training resource tool for clinical research sites. These SOPs can be customized to specific therapeutic areas in consultation with our staff. ClinCoach also offers a one or two day training session with sites for the set of SOPs.
Standard Operating Procedures Purchase Options
Package One: One set of SOPs at $1900.00 plus applicable taxes per site
Includes the package of 20 Standard Operating Procedures
Package Two: Sponsors Purchase:
Help you sites to go for gold in clinical research! Add a budget item for SOPs and training into your next clinical trial!
For an investment of $1900.00 per site the sponsor can provide a set of comprehensive SOPs to all sites, which are ready to use. The sponsor logo will be added to the set of SOPs. For purchase orders of more than 3 sites ClinCoach will negotiate a group price.
The ClinCoach SOP Intellectual Property Legal Policy does not allow sites to photocopy the set of SOPs to be distributed for use. License numbers are supplied to all sites using the set of SOPs.
Package Three: SOP One or Two Day Training Course for Sites
ClinCoach offers a one or two day customized SOP training course for clinical research sites. This session is offered as a per attendee rate up to a certain number of attendees.
SOP Customization at Sites
The ClinCoach SOPs have been written as a comprehensive training resource tool for clinical research sites. These SOPs can be customized to specific therapeutic areas in consultation with our staff.
Consultation fee per hour as negotiated per site.
This rate will be decreased for large numbers of sites.
To order please fill out our order form or click on the E-Mail links below to contact us:
ClinCoach Inc.
118 Ochterloney Street
Dartmouth, NS B2Y 1C7
Canada
Tel: (902) 425-3038
Fax: (902) 425-6879
pjwright@clincoach.com
info@clincoach.com
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