International Laboratory Directories

Certifications, Accreditations, Licenses:

Nonclinical project management Preparation of nonclinical development plans Development and review of nonclinical study designs and protocols Liaison activities with regulatory authorities Integration of nonclinical and clinical programs Selection, qualification, management, and monitoring of nonclinical study sites Good Laboratory Practices (GLP) audits Preparation and evaluation of nonclinical reports Preparation of non-clinical sections for INDs and NDAs Clinical program and management Preparation of clinical development plans and study designs Specialized research studies Network of clinical expert consultants Coordination of team of experts Liaison activities with regulatory authorities Clinical supply management, including labeling and packaging Selection, qualification, management, and monitoring of bioanalytical laboratory, Clinical Research Organization (CRO), clinical trial sites and investigators Good Clinical Practices (GCP) Audits Medical writing Preparation and quality assurance of protocols, case report forms, informed consent forms, Investigator's Brochure, Final Study Reports, Expedited IND, and Postmarket Safety Reports Preparation of clinical sections for INDs and NDAs

**Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this company.