Protocol Clinical Consulting provides project management and operations support for clinical research and development.
Study Management:
CRO and vendor management
Patient recruitment and enrollment initiatives
Cross-functional and clinical team management
Regulatory:
Essential document collection and IRB submissions
Audit readiness trial master file reviews
IND/NDA submission preparation and advisory committee meeting support
Safety Data Monitoring:
Endpoint & Event Adjudication
DSMB/DMC Coordination
SAE and data reconciliation
Monitoring & Site Management:
Visit report review and tracking
Lead CRA and CRA Management
GCP and Protocol-specific Training
Strategic Operations:
SOP development
Process improvement initiatives
Scientific Meeting Coordination:
Investigator meeting planning and event coordination
Scientific and Educational meeting series
KOL/HCP interaction management
Communication planning, meeting logistics and facilitation
Company Details
- Founded
- 2011
- Address
- Austin, Tx 78748, Us
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- http://www.protocolclinical.com
- Keywords
- Project Management, Global Clinical Operations, Process Optimization, Clinical Study Management, Inspection and Audit Readiness, Training Design and Implementation, Meeting Planning and Facilitation, Monitoring, Site Management, KOL Management.
- HQ
- Austin, TX
Protocol Clinical Consulting Llc Questions
Protocol Clinical Consulting Llc's website is http://www.protocolclinical.com
Protocol Clinical Consulting Llc's LinkedIn profile is https://www.linkedin.com/company/protocol-clinical-consulting
Protocol Clinical Consulting Llc's industry is
Pharmaceutical Manufacturing
Protocol Clinical Consulting Llc's top competitors are
Pharmaphase Management, Llc,
Planwerk Solutions,
Clinical Assistance Programs,
Investigative Clinical Research,
The Pharma Agent.co.za,
Brijourn Clinical Research Consulting,
O'keefe Life Sciences Llc,
Coalescence Clinical Consulting Group,
Mobile Massages,
Gcp Vision Consulting.
Protocol Clinical Consulting Llc's categories are Pharmaceutical Manufacturing
Protocol Clinical Consulting Llc's founding year is 2011
