Clinical Trial

Clinical Study for Drugs and Tobacco Products

Clinical Trial Regulatory Compliance Consulting Services

Navigating the complex landscape of clinical trial regulations is critical for the successful development and approval of new medical therapies. Our Clinical Trial Regulatory Compliance Consulting Services are designed to support pharmaceutical companies, biotech firms, and research organizations in meeting stringent global regulatory standards.

With deep expertise in FDA, EMA, ICH-GCP, and other international regulatory frameworks, our consultants offer strategic guidance and hands-on support throughout the clinical trial lifecycle—from protocol development and regulatory submissions to inspection readiness and post-trial reporting. We help ensure compliance, minimize risk, and streamline the path to market for innovative treatments.

Whether you’re launching a new trial or addressing compliance challenges mid-study, our tailored solutions and proactive approach ensure your trials meet both scientific and regulatory expectations.

Clinical Trial Process: Planning & Conduct

Successfully bringing a new drug or device to market in the United States requires precise planning and flawless execution of clinical trials aligned with FDA guidance. Our consulting services are designed to support sponsors and research teams in designing, implementing, and managing clinical trials that fully comply with FDA regulations and expectations.

From early-stage protocol development and IND preparation to site selection, monitoring strategies, and data integrity practices, we provide end-to-end support to ensure trials are scientifically sound and regulatorily compliant. Our expertise spans FDA guidance documents, GCP standards, and evolving regulatory expectations, enabling sponsors to reduce delays, mitigate risk, and achieve approval milestones with confidence.

With a proactive, quality-focused approach, we help you align your clinical operations with FDA requirements—maximizing the likelihood of a successful regulatory review and market authorization.

Clinical trial planning is a critical phase in the drug and device development process, ensuring that trials are strategically designed, ethically conducted, and scientifically valid while meeting regulatory requirements. Effective planning lays the foundation for successful execution and regulatory approval.

1. Defining Clinical Development Strategy

  • Aligning trial objectives with the overall product development plan.

  • Identifying appropriate trial phases (Phase I–IV) based on product maturity and intended indication.

  • Integrating feedback from prior preclinical or clinical studies, advisory meetings, and regulatory interactions (e.g., FDA pre-IND or Type B meetings).

2. Protocol Development

  • Designing scientifically rigorous protocols with clearly defined objectives, endpoints, inclusion/exclusion criteria, and study procedures.

  • Incorporating statistical design, including sample size calculation, randomization strategy, and analysis plans.

  • Ensuring alignment with FDA guidance documents, ICH E6(R2) GCP, and therapeutic-specific regulatory requirements.

3. Regulatory Planning

  • Preparing and submitting regulatory documents such as Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), or amendments.

  • Identifying FDA-required safety reporting and data monitoring procedures.

  • Scheduling regulatory milestones and engaging with the FDA at key development points.

4. Site Selection and Feasibility

  • Assessing potential clinical sites for experience, infrastructure, patient population, and compliance history.

  • Conducting feasibility assessments to determine recruitment capability and site performance.

  • Negotiating contracts, budgets, and site agreements.

5. Trial Budgeting and Resource Planning

  • Developing a detailed trial budget covering personnel, CRO services, site payments, investigational product (IP) costs, and contingency funds.

  • Allocating resources for clinical monitoring, data management, pharmacovigilance, and quality assurance.

  • Identifying and selecting vendors (e.g., central labs, CROs, eCOA providers).

6. Project Timeline and Risk Management

  • Building a comprehensive project timeline with defined milestones and decision points.

  • Identifying potential risks (e.g., delays in recruitment, protocol deviations) and establishing mitigation strategies.

  • Implementing trial governance plans, including steering committees and data safety monitoring boards (DSMBs) where appropriate.

7. Trial Documentation and Compliance

  • Creating a Trial Master File (TMF) structure in compliance with FDA and ICH standards.

  • Developing SOPs, investigator brochures (IBs), informed consent forms (ICFs), and monitoring plans.

  • Planning for inspection readiness and regulatory audit preparedness.

8. Training and Communication Planning

  • Providing GCP and protocol-specific training for investigators and study staff.

  • Establishing communication plans for cross-functional coordination among sponsors, CROs, sites, and regulators.

Outcome of Effective Clinical Trial Planning

Properly executed planning enables:

  • Faster study start-up

  • Higher protocol compliance

  • Improved patient safety and data quality

  • Smoother regulatory interactions

  • Increased likelihood of FDA approval