Lotus has an exhaustive quality assurance team to monitor the clinical activities with the desired quality. 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 Control (QC) and Quality Assurance (QA) procedures. Quality Assurance activities cover Clinical, Bioanalytical, Statistics, Reporting and Internal Audits by QA team for area specific SOP compliance.

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 40 member dedicated team) reports directly to the Management. All 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.

Our expertise conducts various Quality Assurance programs like regulatory inspections and audits by competent authorities / sponsors to assure compliance.

We have competencies to address regulatory and sponsor queries, and recommend best practices based on feedback received.

Lotus Labs has in-house capabilities to perform:

• Site Audits
• Systems / Process Audits
• Vendor Audits
• Document Audits (Protocol, Clinical Study Reports & essential Clinical Trial documents)