Services

Clinical Trials Design

Chauvell has specialized teams with expertise in designing clinical trials, including probiotic studies. We help optimize study design to address specific research questions, select appropriate endpoints, and ensure the trial meets regulatory requirements.

Study Design and Protocol Development:

Collaborate with clients to design scientifically rigorous and ethically sound clinical trial protocols.
Determine appropriate study endpoints, sample size calculations, randomization procedures, and inclusion/exclusion criteria.

Clinical Trials Management

Planning and executing probiotic clinical trials involve numerous logistical considerations, such as site selection, study site management, and coordination of study activities. Chauvell provides logistical support and project management services to streamline trial operations and ensure efficient study conduct.

Logistical Support:

Oversee all aspects of clinical trial operations, including site selection, investigator training, monitoring, and project coordination.
Implement quality assurance measures to maintain data integrity and regulatory compliance throughout the trial.

Patient Recruitment

Recruiting participants for probiotic clinical trials can be challenging due to the need for specific inclusion criteria and the potential for high dropout rates. Chauvell has access to extensive databases and recruitment networks, helping to facilitate the enrollment of eligible participants within the required timeframe.

Participant Recruitment and Screening:

Develop recruitment strategies to identify and enroll eligible participants meeting study criteria.
Conduct thorough screening procedures to ensure participant safety and protocol compliance.

Regulatory Compliance

Probiotic clinical trials are subject to regulatory oversight to ensure participant safety and data integrity. Chauvell has experience navigating the regulatory landscape and can assist with protocol development, obtaining regulatory approvals, and ensuring compliance with applicable regulations throughout the trial.

Regulatory Compliance and Submission Support:

Navigate regulatory requirements and obtain necessary approvals from regulatory authorities (e.g., FDA, EMA, Health Canada).
Assist clients in preparing and submitting regulatory documents, including Investigational New Drug (IND) applications, Investigational Medicinal Product Dossier (IMPD), and Clinical Study Reports (CSRs).

Quality Assurance and Monitoring

Maintaining quality and data integrity is essential in probiotic clinical trials. Chauvell provides comprehensive monitoring and quality assurance services, including site monitoring, data management, and compliance oversight, to ensure the trial is conducted according to protocol and regulatory standards.

Quality Assurance and Auditing:

Implement quality management systems to ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory standards.
Conduct internal audits and external inspections to evaluate compliance with protocol requirements, standard operating procedures (SOPs), and regulatory requirements.

Data Management and Analysis

Probiotic clinical trials generate large amounts of complex data that require careful management and analysis. Chauvell offers expertise in data management, statistical analysis, and interpretation, helping to ensure the accuracy and reliability of study findings.

Data Collection and Management:

Utilize electronic data capture (EDC) systems to collect, manage, and analyze trial data efficiently.
Ensure data accuracy, completeness, and confidentiality in accordance with regulatory requirements.