Excellent Performance

The ClinSearch research team is committed to the highest standards of performance in the conduct of clinical trials completed at our facility. We adhere stringently to all GCP and ICH guidelines, Federal regulations and the study protocol. Every study is assigned a primary, as well as secondary, research coordinator that is fully prepared to assume the duties of the primary coordinator on a temporary or permanent basis. ClinSearch performs quality assurance audits on all trials which may include the examination of the investigator site file, source documents, case report forms, patient informed consent, inclusion/exclusion criteria, compliance with SOPs, monitoring reports and query resolution process. All results are discussed with appropriate team members.

ClinSearch has a complete list of SOPs that govern the performance of all procedures of a clinical trial unless replaced by a specific study protocol or SOP. The topics covered are listed below.

Pre study site visit Patient screening and telephone interviewing
Study initiation procedures Developing and obtaining informed consent
Source documentation procedures Case report form completion & DCF resolution
Drug accountability & dispensation Electronic records & electronic signatures
Serious adverse event reporting Regulatory binder & study files maintenance
Monitoring visit Quality assurance
Study closeout procedures HIPPA compliance policy
CRO/Sponsor audit preparation Minimum necessary use & disclosure of PHI
FDA audit preparation Verification requirements for disclosure of PHI
Patient/Volunteer recruitment Individual’s request for access to PHI
Protocol specific training Amendment of protected health information
Employee training Authorizations for use and/or disclosure of PHI
Maintenance of equipment Notice of privacy practices
Physician recruitment Fire evacuation procedures
Liability insurance Non-compliance/disciplinary action
Company structure & delegation Computerized systems used in clinical investigations
SOP preparation and revision

ADDITIONAL INFORMATION: