Michael CCRP

Regulatory Affairs Associate at NCGS, Inc. - Charleston, SC, US

Michael CCRP's Contact Details
HQ
843-722-8330
Location
Company
NCGS, Inc.
Michael CCRP's Company Details
NCGS, Inc. logo, NCGS, Inc. contact details

NCGS, Inc.

Charleston, SC, US • 250 - 499 Employees
Major Drugs

NCGS, Incorporated is a full-service international CRO managing clinical trials since 1984 in drug, biologic, device, diagnostics and consumer products. NCGS provides full-service or strategic sourcing needs focused on risk mitigation. Contingency planning is actively employed, not just planned for. NCGS is a WBENC certified diversity supplier.NCGS has supported the development or expanded labeling of 78 approved products and has ZERO 483s. NCGS clinical teams are first in class, highly- tenured professionals - 10+ years' experience; A team remains throughout the trial- Turnover rates are discernibly different at less than 3% annuallyCLINICAL TRIAL THERAPEUTIC FOCUS INCLUDES: - Neuro-Psych (CNS)- Infectious Diseases / Critical Care- Oncology, hematology, transplant- Trials in multiple other areas have been conducted ROBUST DIVISION OF COMPLIANCE & RECRUITMENT SPECIALIST- CAPA initiatives- Due diligence auditing - eTMF- Subject recruitment- Call Center 24/7- Trial Rescue- Safety, SAE narratives and SAE reconciliationFULL SERVICES INCLUDE:• Clinical Operations and Monitoring• Fully Integrated e-Based iCloud Systems- e-REMOTE: Risk-based monitoring- eTMF: TMF Migration, Consolidation- ePAY: Grants, Contracts, Payments- eDM: EDC, IWRS- ePRO:Patient Reported Outcomes- eCLIN: CTMS• Medical Monitoring & Clinical Safety • Quality Assurance & Regulatory Compliance• Global Strategic Sourcing• Medical Writing• Biostatistics

Clinical Operations & Monitoring Data Management (EDC) eTMF- Manage Migrate Merge Medical Monitoring CTMS GCP/ICH Compliance Safety Narrative and SAE Reconciliation Contracts-Site and Vendor Payment Medical Writing IWRS Strategic Sourcing Clinical Operations & Monitoring Major Drugs Pharmaceutical Preparations Pharmaceuticals
Details about NCGS, Inc.
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Michael CCRP currently works for NCGS, Inc..
Michael CCRP's role at NCGS, Inc. is Regulatory Affairs Associate.
Michael CCRP's email address is ***@ncgs.com. To view Michael CCRP's full email address, please signup to ConnectPlex.
Michael CCRP works in the Pharmaceuticals industry.
Michael CCRP's colleagues at NCGS, Inc. are Tyler Clem, Aleks Knuepfer, Christine Blice, Mateo Aycardi, Jonathan Richardson, William Duke, Deirdre Walker and others.
Michael CCRP's phone number is 843-722-8330
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