Quality Assurance

Clinical and Laboratory Quality Assurance Programs

The quality assurance team at Lotus, focuses on the quality that pervades the entire gamut of processes within the ambit of all services at Lotus Labs – reflected in meticulous implementation of various Quality Assurance (QA) procedures. Our Quality Assurance activities cover audits of Clinical, Bio analytical, Patient based studies, Statistics including CDISC, Data management, Medical writing for all studies conducted at Lotus Labs. Additionally facility and system based Internal Audits are conducted by QA team for all areas to verify compliance as per our stated requirements. The QA team also regularly performed vendor audits as per our defined procedures.

We have also instituted routine training & qualifying tests to keep all personnel abreast with the latest developments and have also ensured uniformity and consistency by implementing process standardizations at all levels. The QA Head (leading a check 21) member dedicated team) reports directly to the Managing Director. All Laboratory and Clinical Quality Assurance systems at Lotus Labs are compliant with relevant local & international regulations.

At Lotus our central archival facility is designed with utmost security and is temperature & humidity controlled to ensure long term archival of study and related documents. All studies are digitally archived for back-up retrievals.

We have successfully completed all our regulatory inspections and sponsor audits and have demonstrated high levels of compliance to all the regulatory requirements.

We have competencies to address regulatory and sponsor queries, and we continually improve our practices based on feedback received.