Streamlined Clinical Solutions for Life Sciences Success

At Excellence Squad, we provide comprehensive clinical solutions to support every stage of your clinical development journey. From strategic trial design to post-market studies, our services ensure compliance with Good Clinical Practice (GCP) and global regulatory requirements while optimizing efficiency and outcomes. Partner with us to streamline your trials, safeguard patient safety, and accelerate your path to success.

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Clinical Trial Strategy and Design

Develop strategic clinical trial plans that comply with Good Clinical Practice (GCP) and regulatory requirements, optimizing study outcomes and approval timelines.

Clinical Study & Site Management

• Oversee clinical trials from inception to completion, ensuring GCP compliance, efficient resource allocation, and seamless coordination across stakeholders.
• Monitor trial sites and activities to ensure adherence to protocols, regulatory requirements, and performance benchmarks.

Clinical Evaluation Reports (CERs)

Prepare CERs for medical devices in accordance with EU MDR requirements, providing thorough assessments of clinical safety and performance.

Clinical Data Integrity & Management

• Ensure the accuracy, integrity, and compliance of clinical trial data with GCP, 21 CFR Part 11, GDPR, and global regulatory standards to support reliable decision-making for submissions.
• Safeguard against data manipulation and ensure accurate, reproducible results in clinical research.

Regulatory Submissions for Clinical Trials

Provide support for IND/CTA submissions, ensuring that all clinical trial documentation meets regulatory authority expectations and facilitates approval.

Clinical Risk & Safety Management

• Conduct clinical trial risk assessments to identify and mitigate potential risks to patient safety, data integrity, and trial outcomes.
• Manage safety data collection and adverse event reporting during clinical trials to safeguard patient well-being and ensure compliance.
  

Post-Market Clinical Follow-Up (PMCF)

Support post-market activities to assess the long-term safety, performance, and efficacy of medical devices, in compliance with MDR requirements.

Biostatistics and Data Analysis

Deliver comprehensive statistical analysis for clinical trial data and regulatory submissions, ensuring robust evidence to support product claims.

Study Close-out

Manage all aspects of clinical study closure, including final reports, close-out meetings, and compliance reviews, to ensure a seamless transition to post-market phases.

Real-World Evidence (RWE) and Post-Market Studies

Assist in the collection and analysis of real-world evidence (RWE) from patient populations post-market. Demonstrate long-term safety, efficacy, and value in support of regulatory compliance and market adoption

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