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Clinical Research

Early-stage Clinical Development

Integrated solutions to accelerate your HealthTech product development process​

Early-stage clinical development, typically encompassing Phase I and Phase II trials and presents several challenges, including: 

  • Patient recruitment
  • Scientific uncertainly
  • Regulatory compliance 
  • Resource constraints
  • Competitive landscape
  • Manufacturing challenges
  • Endpoint selection
  • Data interpretation

Overcoming these challenges requires careful planning, collaboration among stakeholders, adherence to rigorous scientific and ethical standards, and sometimes, a willingness to adapt strategies in response to unexpected developments.

What we offer:​

Our expert team is dedicated to accelerating your drug development journey with integrated solutions, from Phase I through Phase II trials. With a proven track record of success, cutting-edge technology, and a commitment to regulatory compliance, we are here to help you bring life-changing therapies to market faster and more cost-effectively.

  • Protocol Development: Assistance in designing the clinical trial protocol, including study objectives, patient inclusion/exclusion criteria, and endpoints. CROs provide expertise in optimizing study design.
  • Regulatory: Assistance with regulatory submissions and interactions with regulatory authorities to ensure compliance with local and international regulations.
  • Site Selection and Management: Identifying and selecting appropriate clinical trial sites, managing site contracts, and providing ongoing site support to ensure smooth trial execution.
  • Patient Recruitment and Retention: Developing strategies to enroll and retain study participants, which is critical in early-stage trials with small patient populations.
  • Clinical Monitoring: Conducting regular site visits to ensure data quality, patient safety, and protocol compliance. This includes source data verification and adherence to Good Clinical Practice (GCP) guidelines.
  • Data Management and Biostatistics: Collecting, managing, and analyzing clinical trial data, including the development of statistical analysis plans and generation of study reports.
  • Safety Monitoring: Continuous monitoring and reporting of adverse events to regulatory authorities, as well as implementing safety protocols to protect trial participants.
  • Quality Assurance and Auditing: Ensuring that all trial activities adhere to regulatory and GCP standards through quality assurance and auditing processes.

Why work with us?​

Agile project management:

Overseeing all aspects of the clinical trial, including timelines, budgets, and resource allocation, to ensure that the trial stays on track.

Strong scientific and medical expertise: 

Providing access to medical experts who can contribute to trial design, safety assessments, and data interpretation.

In-house interdisciplinary experts:

Our experts include scientists in the field of regulatory, CMC, market access and data management.

Cost efficiency: 

We offer transparent cost structures and budgeting, ensuring you get the most value from your investment.

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