Services offered

• Local and International Expertise:

Keena Consulting offers comprehensive clinical project management services for both local and international clinical studies.

We oversee the entire process, from study planning through execution and closure, ensuring strict compliance with regulatory requirements and study protocols.

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• Operational Management:

The clinical project manager ensures rigorous management of deadlines, budgets, and resources, while maintaining fluid communication with investigators and local teams.

• Monitoring Activities:

Keena Consulting provides highly experienced Clinical Research Associates (CRAs) to manage on-site and remote monitoring activities.

Our CRAs are responsible for ensuring that clinical studies comply with Good Clinical Practices (GCP), ensuring the quality and integrity of the data collected.

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• Continuous Supervision:

Our ARCs ensure regular monitoring of investigation centers, evaluation of patient inclusion/exclusion criteria, data management as well as compliance with study protocols and regulations in force.

• Preparation and Submission of Files:

We assist our clients in the preparation and submission of regulatory dossiers to the relevant authorities.

This includes managing clinical study submissions, preparing Clinical Trial Authorization Application (CTA) dossiers, and submitting for CE markings for medical devices.

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• Compliance with European and International Regulations:

Thanks to our expertise in European and international regulations (EMA, FDA, CE, etc.), we ensure that all submitted files meet the standards required for rapid and compliant marketing.

Advice and Expertise:
We offer personalized support and solutions tailored to the needs of each client, providing them with ongoing support for clinical studies and regulatory submissions.