Clinical Services

Advancing MedTech Clinical Trials with Integrated Clinical, Regulatory, and Scientific Expertise, Powered by Boutique CRO Capabilities

Designing and managing clinical trials is complex, costly, and time-consuming. As experienced MedTech consultants, we ensure our clients' trials succeed through strategic, operational, and regulatory expertise. We keep stakeholders informed with regular updates and address concerns promptly for transparency and alignment. Here's how we ensure success:

Our Clinical Services Scope

Our Clinical Services Coverage

Guidance and Strategy

Navigating Regulations: We ensure full compliance with global authorities like the FDA and EMA, designing and executing trials to meet all legal and safety standards.
Early Regulatory Strategy: We create tailored regulatory strategies (e.g., IDE, PMA) to ensure smooth approvals and swift progression through key stages.
Risk Management: We create risk management strategies following ISO 14971, identifying and mitigating risks early to protect the trial’s integrity.

Design and Planning

Clinical Endpoints: We define clinically relevant and meaningful endpoints to support future product approval.
Trial Documents: We design protocols, consent forms, and case report forms that meet regulatory, ethical, and outcome requirements for trial success.

Site Selection and Management

Site Selection and Assessment: We choose optimal trial sites, maximizing recruitment and data quality through experience and access to target populations.
Site Support: We provide ongoing training, resources (e.g., regulatory and subject binders), and support to ensure protocol adherence, regulatory compliance, and efficient operations.

Ethical and Compliance Oversight

Ethics Approval: We ensure all trials obtain the necessary Institutional Review Board (IRB) or Ethics Committee (EC) approval before commencement. With extensive experience working with both local and centralized IRBs, we navigate the ethics review process efficiently.
GCP Compliance: We create monitoring plans and forms to ensure Good Clinical Practice (GCP) compliance, protecting data integrity and participant safety. Monitoring can be done remotely or on-site.

Data Management and Analytics

Data Integrity: We ensure clinical trial data is consistent, accurate, and secure, using advanced technology to capture, clean, and store per GCP guidelines.
Statistical Analysis: We work with biostatisticians to create precise statistical analysis plans (SAP), ensuring accurate data interpretation and actionable insights.

Project Management and Timelines

Timely Execution: Our expert project management ensures trials stay on schedule and within budget, overseeing all milestones from recruitment to data collection.
Contingency Planning: We proactively address potential challenges like site delays and recruitment issues, ensuring smooth trial progression.

Patient Recruitment and Retention

Recruitment Strategies: We use targeted outreach, partnerships with patient advocacy groups, and advanced technologies to effectively recruit hard-to-reach patient populations.
Retention Plans: We create strategies to minimize dropout rates, keeping participants engaged and addressing their needs throughout the trial.

Post-Trial Support

Data Interpretation: After trial completion, we help interpret results, identify trends, and provide actionable insights for product development.
Regulatory Submissions and Reporting: We prepare annual progress report (APR) and clinical study report (CSR), facilitating regulatory submissions like PMA or CE marking to ensure compliance and speed up market entry.
Commercialization Strategy: We guide clients through the transition from trials to market launch, including post-market surveillance and ongoing regulatory compliance for long-term success.

Our Boutique CRO Vs. Large CROs

Examples of Completed Clinical Services (Including but not limited to):

Design of an investigational device exemption (IDE) clinical trial
Development of study documents for a class II insulin pump
Design of an investigator-initiated post-market observation (PMO) study and development of study documents for a class II pain therapy device
Clinical research support for a Class II, AI-based Algorithm, FDA study
- Development of Study Protocol, SAP, ICF, and Safety Plan
- Development of Monitoring Plan and Forms, CRFs, Regulatory & Subject Binders
- Identification of research-ready institution and site assessment
- Interaction with WCG and local IRBs
- Site initiation visit presentation and study training
- Site activation, interaction, and compliance
- Enrollment tracking, weekly status updates, site newsletters
- In-house EDC and TMF