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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 1 and Phase 2 trials and presents several challenges, including: 

  • Patient population definition and subsequent recruitment
  • Scientific uncertainly for a new MOA
  • Regulatory compliance and disparities across development regions
  • Resource constraints
  • Competitive landscape
  • Manufacturing challenges
  • Endpoint selection and alignment between health authorities and varying standards of care across regions
  • 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 1 through Phase 2 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 interactions with regulatory authorities, for example, a US pre-IND meeting, to ensure compliance with local and international regulations and achieving successful health authority submissions.
  • 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.


What is meant by early phase trial?

Early phase trials often refer to phase I and I/II trials and are the initial stages of the clinical development of a new treatment. They are focusing on safety, tolerability, possibly early signals of potential activity of a drug in a small group of patients. Their results help to select appropriate doses for subsequent steps.

No, early phase clinical trials do not necessarily involve healthy volunteers.

Although testing with healthy volunteers is common in the early phases of clinical trials to evaluate the safety and tolerability of a drug, in some cases the inclusion of healthy volunteers may not be ethical and these trials may include patients. This is particularly the case for serious or fatal diseases or toxic drugs (for example, cytotoxic products in oncology). In these cases, the goal may be to evaluate both the safety and potential activity of the treatment. These trials can primarily aim to determine the optimal dose, understand the mechanisms of action of the drug and collect data on its activity in the targeted population.

Early phase clinical trials, whether they include healthy volunteers or patients, are essential for the development of new treatments and their proper conduct is essential to de-risk the overall development.

Yes, it is common to use a placebo in phase I clinical trials.

These trials aim to evaluate the safety profile, tolerability and the first signs of potential activity of a drug in humans. In many cases, a placebo is used as a control group to compare the effects of the test drug versus no treatment. When the study design includes the use of a placebo, it is recommended at the initiation of each cohort to simultaneously treat one subject with the active treatment and one with placebo before dosing other participants of the cohort.

However, note that in some cases the use of placebo is not ethically acceptable and therefore all participants receive the study treatment.

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