Syngene’s clinical development business group serves pharmaceutical and biotechnology companies across the globe in conducting clinical research from early-phase through late-phase clinical trials across a wide range of therapeutic areas.

Services include:

• Phase I- bioavailability/ bioequivalence (BA/BE) studies
• Clinical trial management
• PK/bioanalytical (small molecules and biologics)
• Central Laboratory
• Integrated eClinical services
• Clinical data management and biostatistics
• Regulatory affairs
• Medical monitoring
• Pharmacovigilance
• Medical writing

GCP Quality group comprises clinical quality assurance team, bioanalytical quality assurance team, an independent quality systems management team and quality improvement teams. Together, they are responsible for administration of quality management systems for activities undertaken by clinical development.

This is to ensure compliance with national and international regulations and guidelines mandated by various regulatory authorities. They conduct study audits and routine systems audits of various functions of clinical development operations and quality management systems including important vendor/supplier qualification and surveillance audits.

Clinical quality assurance is responsible for conducting audits BA/BE, early phase in-house healthy volunteer studies and onsite audits of clinical trial investigation sites for early and late phase studies. It is also responsible for ensuring compliance with ICH-GCP by performing audits in clinical data management and biostatistics functions. Clinical quality assurance also ensures compliance with CAP and NABL (ISO 15189) requirements in Central Laboratory.

Bioanalytical quality assurance is responsible for audits of study process, data and method validation of bioanalytical laboratory and pharmacokinetic data.