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Clinical Research

Clinical Operations

Boutique CRO approach to deliver personalized and high-quality clinical trial management

We understand each clinical trial is unique and requires a customized approach. Our dedicated team of experts works closely with you to develop tailored solutions that align with your study objectives, timelines, and budget. As a small CRO, we are agile and flexible, allowing us to adapt quickly to your evolving requirements and deliver optimal results.

Our expertise:​

Specific development phase:

  • Exploratory
  • Confirmatory 
  • Observational studies
  • Expanded Access Program

What we offer:

  • Study setup with a robust feasibility step
  • Study conduct, management and coordination 
  • Study documents management 
  • Clinical Research Associates (CRA) management
  • Management of site contracts and fees 
  • Monitoring activities including site interactions and remote monitoring
  • Data management and biostatistics
  • External Committees management (e.g. DSMB)
  • Logistics management incl. access to central laboratories via our preferred partners


What are the major milestones of each clinical trial?

Clinical trials typically go through several key milestones, but specific details can vary based on the type of trial and the therapeutic area. Here below are the critical steps for a clinical trial:

  1. Study design & Protocol authoring are essential to define study objectives and ensure alignment with the clinical development plan.
  2. Study feasibility will help to assess whether the study is viable in terms of timelines, targeted population, and help to fine tune the regulatory strategy.
  3. Regulatory Approvals need to be obtained before starting any patient recruitment activities and help to ensure that the study is ethical and meet safety standards.
  4. Study conduct which encompasses monitoring and data collection
  5. Study Completion once all patients are completed and final data collected as planned per the protocol.
  6. As the final step, data analysis and reporting during which collected data are analyzed and a clinical study report is prepared.

To enhance patient retention in clinical trials, sponsors need to:

  1. Ensure clear and ongoing communication, building trust between patients and site staff.
  2. Create a patient centered project that focuses on their needs and concerns.
  3. Educate patients on the study’s benefits and their role in developing product knowledge.
  4. Facilitate patient’s journey and streamline procedures to minimize the burden on patients and utilize decentralized technologies for remote data collection.
  5. Provide ongoing education about the study’s progress to maintain patient engagement.

Clinical trials for rare diseases present unique challenges due to the limited number of patients and limited existing knowledge on the disease. Recruitment difficulties often arise, requiring involvement of patient associations. Patient advocacy groups play a crucial role in raising awareness and facilitating study participation.

Regulatory agencies may offer incentives, such as orphan drug designation, to encourage research in rare diseases.

Flexibility in study design and endpoints are necessary to overcome the heterogeneity in rare diseases. Adaptive trial designs allow for real-time adjustments based on new data.

Patients need to be empowered and patient-reported outcomes gain significance in assessing treatment efficacy.

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