Quality Assurance and Compliance

CEBIS India is a CRO where the quality and data integrity is accorded a prime importance. We the team at CEBIS are committed to high quality standards in all areas of our operations. All the projects and activities at CEBIS are conducted in accordance with local DCGI standards and international quality standards. CEBIS follows the best practices and ethical principles to ensure that our clients and regulatory authorities are provided the best possible services.

The Quality management systems at CEBIS are designed to comply with local & international quality standards. e.g. Principles of Good Clinical Practice and ICH guidelines which covers the following components :

• Comprehensive Standard Operating Procedures (SOPs) detailing roles, responsibilities and duties of all personnel.
• A detailed audit plan designed well in advance.
• Maintaining quality at all levels.Approval to conduct BA-BE studies/clinical trial in India.

The QA department is an independent unit reporting to the Managing Director of the company. The main focus of QA team is to conduct the regular online audits during the conduct of studies, audit of post study activities and continual improvement of quality management system.

Our QA team has in-house capabilities to perform:

• Site Audits
• Systems | Process Audits
• Vendor Audits
• Document Audits (Protocol, Clinical Study Reports & essential Clinical Trial documents)
• GCP compliance review
• IRB | EC audits
• Drug accountability reviews
• Study document reviews
• Internal Audits for Area Specific SOP compliance

All our QA systems are compliant with all applicable local & international regulations