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

• GCP, GLP, and GMP Training

• Clinical Research Center Development

• Clinical Research Project Management and Monitoring

• 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.

• 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.

• Develop efficient systems and infrastructure for setting up clinical research centers.

• Provide research center feasibility assessments and gap analysis for study start up.

• 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.