Drug Development Services
SciReg, Inc. offers a full spectrum of drug development services that enable expert and efficient development of your product. SciReg’s professionals have extensive domestic and international experience in drug development, providing a range of early and late phase consulting services in the areas of:
GCP, GLP, and GMP Quality Assurance Support
- Serve as a sole, third-party Quality Assurance Unit, or as a QA resource on a project-by-project basis.
- Perform GCP, GLP, and GMP quality assurance audits of study protocols, reports, raw data, vendors (laboratories, IRBs/EC, CROs, data management , manufacturing facilities, etc), sponsors, and clinical research centers; identify compliance issues; recommend and help implement corrective actions; defend client compliance practices with regulatory agencies.
- Provide corrective and preventative action programs.
- Conduct for-cause GCP, GLP, and GMP audits.
- Prepare sponsors, CROs, and clinical research centers for FDA and EMEA inspections.
- Prepare, maintain, and distribute Standard Operating Procedures.
- Identify and interpret national and international regulatory requirements; provide compliance recommendations.
GCP, GLP, and GMP Training
- Prepare and present training programs in GCP, GLP, and GMP to sponsor organizations and research centers.
- Prepare and present CRA training.
- Prepare and present 21 CFR Part 11 training.
- Tailor existing training programs to better suit the client’s needs and areas of focus within the organization.
Clinical Research Center Development
- Develop efficient systems and infrastructure for setting up clinical research centers.
- Provide research center feasibility assessments and gap analysis for study start up.
Clinical Research Project Management and Monitoring
- Provide complete contract negotiations that include, but are not limited to, site negotiation, payment for services, and consulting outsourcing for the conduct of clinical trials.
- Provide tracking, oversight, and execution of contract/grant payments to clinical research centers and outside consultants.
- Maintain and execute oversight and management of contractors including CRO's, central laboratories, and independent consultants.
- Identify and assist clients in establishing and maintaining study milestones and deadlines throughout the conduct of the clinical trial.
- Initiate, implement, and manage Phase I-III trials.
- Design and prepare study-specific materials (ICF, CRFs, SOPs, monitoring reports, etc.).
- Provide IRB/EC and regulatory support.
- Monitor phase I-III clinical trials including pre-clinical/qualification visits, initiation visits, interim monitoring visits, and close-out visits.
- Collect, review, and submit monitoring visit documentation.
Please contact us for more information regarding our services.
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