Biologics
Clinical Development
- Clinical Study Design and Planning: Designing and planning clinical studies for biologic products.
- Clinical Trial Execution: Managing the execution of clinical trials to ensure compliance and data quality.
- Clinical Data Management: Handling data from clinical trials to ensure accuracy and regulatory compliance.
- Biostatistics and Analysis: Applying biostatistical methods to analyze clinical trial data.
- Clinical Study Monitoring: Monitoring clinical studies to ensure compliance with protocols and regulatory requirements.
Regulatory Affairs
- Regulatory Pathway Strategy: Developing strategies to navigate regulatory pathways for biologics.
- IND/CTA/BLA/MAA Submissions: Preparing and submitting regulatory documents for investigational and marketing approvals.
- Regulatory Compliance Training: Providing training on regulatory requirements and compliance for clinical trials.
- Gap Analysis and Remediation: Conducting gap analyses to identify and remediate compliance issues.
Pharmacovigilance
- Safety Surveillance: Monitoring the safety of biologic products during clinical trials.
- Adverse Event Reporting: Reporting adverse events to regulatory bodies.
- Risk Management Plans: Developing plans to manage risks associated with biologic clinical trials.
- Safety Data Analysis: Analyzing safety data to ensure the safety of trial participants.
Pharmaceuticals
Clinical Research
- Clinical Trial Manager
- Clinical Data Manager
- Biostatistician
- Clinical Research Associate
Regulatory Affairs
- Regulatory Affairs Specialist
Pharmacovigilance
- Drug Safety Specialist
- Drug Safety MD
Medical Devices
Clinical Operations
- Clinical Trial Manager
- Clinical Data Manager
- Clinical Project Manager
- Clinical Research Associate
Regulatory Affairs
- Regulatory Affairs Specialist
Post-Market Surveillance
- MDR Specialist
- Complaint Handling Specialist
Biologics
Clinical Operations
- Clinical Data Manager
- Data Manager
- Biostatistician
- Clinical Research Associate
Regulatory Affairs
- Regulatory Affairs Specialist
Pharmacovigilance
- Drug Safety Specialist
- Drug Safety MD