Clinical Consulting Services

Pharmaceuticals

Clinical Research

• Clinical Trial Management: Overseeing clinical trials from start to finish, ensuring compliance with protocols and regulatory requirements.
• Protocol Development: Creating and refining clinical trial protocols to meet scientific and regulatory standards.
• Investigator Site Management: Managing relationships with clinical trial sites and ensuring adherence to trial protocols.
• Clinical Data Management: Ensuring the accurate and secure handling of clinical trial data.
• Biostatistics and Data Analysis: Applying statistical methods to analyze clinical trial data and ensure its integrity.

Regulatory Affairs

• Regulatory Strategy Development: Formulating strategies to navigate regulatory pathways for clinical trials.
• Regulatory Submissions and Approvals: Preparing and submitting regulatory documents for clinical trial approvals.
• Regulatory Compliance Audits: Conducting audits to ensure compliance with regulatory requirements.
• Regulatory Liaison Services: Acting as a liaison between companies and regulatory bodies.

Pharmacovigilance

• Adverse Event Reporting: Monitoring and reporting adverse events during clinical trials.
• Risk Management Plans: Developing and implementing plans to manage risks associated with clinical trials.
• Signal Detection and Management: Identifying and managing safety signals during clinical development.
• Safety Data Analysis: Analyzing safety data to ensure the well-being of trial participants.

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Medical Devices

Clinical Affairs

• Clinical Evaluation Reports: Preparing reports that evaluate the clinical performance and safety of medical devices.
• Clinical Trial Management: Managing clinical trials for medical devices to ensure compliance and data integrity.
• Clinical Data Management: Ensuring the accurate and secure handling of data from medical device trials.
• Clinical Operations: Overseeing the day-to-day operations of clinical trials.
• Clinical Project Management: Coordinating and managing clinical projects to ensure they meet timelines and budgets.

Regulatory Affairs

• Technical Documentation Remediation: Updating and correcting technical documentation to meet regulatory standards.
• FDA Submissions: Preparing and submitting documents for FDA approval of clinical trials.
• International Submissions: Managing submissions to international regulatory bodies.
• Regulatory Strategy: Developing strategies to navigate the regulatory landscape for medical devices.
• Lifecycle Management: Managing the regulatory lifecycle of medical devices from development to post-market.

Post-Market Surveillance

• Audit Readiness: Preparing for and managing audits by regulatory bodies.
• Complaint Handling and Reporting: Managing and reporting complaints related to medical devices.
• Field Safety Corrective Actions (FSCA): Implementing corrective actions for safety issues identified in the field.

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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