NOLA Research Works is a multi-specialty research clinical research center in New Orleans.
By keeping the focus on research, NOLA Research Works and Women Under Study are able to dedicate all of their time to remaining motivated and resolute in their commitment to setting the new standard for clinical research sites.
Commitment To Sponsors:
Implement, execute and monitor safe and accurate protocol-based clinical trials in accordance with good clinical practice guidelines.
5 – 7
days for IRB review
5 – 10
days for contracting process
5 – 10
day source generation and staff training
- Full-time MD presence on-site
- CMO with over 45 years of research experience
- PI accessibility and oversight 24 hours a day
- Adequate staffing to ensure proper study management which includes Site Director, Regulatory Director, two Senior CRC project managers, two clinical research coordinators, two research assistants, two Administrators, one laboratory manager, dedicated pharmacists, blinded and unblinded, one marketing director and two recruiting support staff
- Solid Standards of Procedure and documented annual training
- To continue to elevate the discussion about the benefits of clinical research in an effort to respond to the crucial need for the representation of all demographics in clinical trials.
- To engage and retain subjects by fostering an environment based on respect, beneficence and learning while understanding the guidelines for placebo mitigation.
- To consistently meet and exceed enrollment goals by providing a dedicated recruitment and marketing team, utilizing social and web-based media along with traditional advertising resources.
- To respect study milestones and timeline requirements for enrollment and data integrity. Our dedicated quality assurance staff ensures
- 72 hour turn around for data entry
- 24 hour turn around for query response
- Expedient SAE, pregnancy and deviation reporting to IRB
- To remain expedient in study start-up including budget, contracting and regulatory approvals and submissions. Dedicated regulatory and startup staff are on site to fulfill regulatorily and startup needs.
- To provide comfortable, effective facilities for patients and sponsors alike
- Dedicated in-temp monitored, locked pharmacy equipped with 24 hour monitored ambient, refrigerated, and 20 below capabilities ( separate freezer for PK storage. Double locked cabinets available for unblinded protocols. Back-up Generator hard wired to pharmacy for emergency outages.
- Dedicated monitoring space with high speed wireless internet, dedicated copy machine and phone line for monitoring staff
- IV infusion room ( three IV pumps, staff trained in asceptic technique)
- Private space for consent
- Comfortable waiting room with access to films and informational health videos
- Dedicated space for medical records
- Four exam rooms including dedicated handicapped exam room
- Dedicated CLIA lab, two centrifuges , incubator, autoclave and adequate storage for all study materials, daily dry ice delivery, PK capabilities
- Three EKG machines
- Ultrasound Equipment ( Chison Q-9) and sonographer
- Colposcopy and Biopsy Room
- Off-site storage for long term document storage
- Dedicated Regulatory space
- Conference Room
- Comfortable monitored outdoor space for long term patient stays
- Fully equipped kitchen for monitor and staff use as well as long patient stays