Clinical Operations

Our team is experienced in managing clinical trials of varied size and complexity in different therapeutic areas like Infectious Diseases, Oncology, Cardiology, Gastroenterology, Nephrology, Diabetes, Obstetrics & Gynaecology, Urology, Pain Management, Dermatology, Ophthalmology, Neurology, Psychiatry and Parental nutrition.

Our team has executed many NDA, ANDA and Biosimilar products clinical development programs including vaccines. The team is comprised of people with the right attitude, flexibility, reliability and commitment to excellence.

Our team shares the same understanding of standard operating procedures and regional operational requirements to facilitate Phase I to IV clinical trials including proof of concept study. Croissance have execution-level experience in most Asia Pacific countries like the Philippines, Malaysia, Indonesia, Sri Lanka and Bangladesh. Our team has managed studies as small as 24 patients (phase I study) to 100,000+ patients (cluster base large community) study where we have managed all the activities from initial set-up to study close out.

Our clinical research associates are trained and experienced to evaluate and enhance vendor and site performance. Our project managers are fine-tuned for planning all project-related activities and communication. These characteristics enable them to comfortably manage the risks and challenges that come during clinical trial execution.

Our operational expertise can be utilised for Phase I to IV clinical trials including proof of concept study. We are specialised in managing the following activities :
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Capacity building
& training nive sites

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Clinical risk base
& medical monitoring

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Clinical study
planing & execution

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DSMB meeting
Co-ordination

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EC
Co-ordination

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Regulatory
support

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Site &
study audits

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Site identification
& feasibility

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Site training
& SOP development

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Study close
out activities

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