LAXAI's Clinical Operation team can manage entire studies or work as an integral part of your existing study team. Our Clinical Operations team members are from life sciences background primarily with nursing and pharmacy degrees and most of the team members are ACRP certified. In addition, they go through an internal mandatory training program comprising of GCP, HIPAA, protocol review, 21 CFR Part 11, SOPs, regulatory affairs & compliance, CRF data entry and documentation. With LAXAI you can be rest assured of exceptional service quality at affordable costs. LAXAI can provide support in different areas of Clinical Operations such as:
Study conduct as per GCP guidelines on-time and on-budget
Site Management
SOP preparation
Assist in regulatory affairs and approvals
Project Management
Source Document verification
Drug Accountability and Clinical Supplies
CRF Data entry and Query Resolution for both EDC and paper based systems
Engagement Models
LAXAI provides Clinical Operations support both in US and India. LAXAI's Clinical Operations team is headed by a Senior Project Manager with an average of 10+ years of experience. The Project Manager leads a dedicated team of Clinical Operations to ensure smooth conduct of the study and is responsible for managing the budgets, timelines and milestones.
