Dr. Samir Arora & his team of experts at Aventiv Research have over 25 years of combined experience in the field of medical research. We have been acknowledged for our compliance, recruitment, and the quality of work that we deliver. Our staff possesses the knowledge and background to assist you in your research needs.
We utilize CRIO, the industry’s leading eSource, CTMS, and eRegulatory software for clinical trial sites. CRIO, is a holistic paperless platform for conducting clinical trials that reduces data errors, streamlines regulatory workflows and accelerate timelines.
Our Clinical Trial Consulting Services include:
New Site Start-Up & Improvement/Enhancement:
- Standard Operating Procedures: Help with the creation, modification, and implementation of site or company-specific Standard Operating Procedures (SOPs).
- Business Development: Assist with expanding and improving the clinical study pipeline available to sites with three, full-time Business Development staff specializing in both Early Phase and Phases II-IV.
- Operations and Staffing: Consult on staffing and infrastructure to provide recommendations on current organizational health, training opportunities, and future partnerships.
- Quality Assurance and Auditing: Perform Internal Audits at your site with a focus on tracking protocol deviations, queries, and adherence to GCP, internal and sponsor SOPs, and regulatory guidelines; provide corrective and preventative action plan tools and root cause analysis.
- Site Engagement and Management: Provide guidance on site selection – including preparation of detailed questionnaires – and oversight in adherence with company guidelines. Assistance with budget and contract negotiations; provide marketing & recruitment Strategies.
- New Site Start-Up: Initiate and oversee research activities within private practices; conduct initial site set up, business development outreach, provide staffing for conduction and oversight of trials, and provide necessary training to new investigators and ancillary staff as needed.
- Develop Project Management outlines, ensure adherence and oversight throughout the course of a trial/project.
- Develop and provide progress reports to track the progression of the trial/project.
- Identify and Contract Appropriate Vendors for project completion.
- Prepare necessary regulatory documents including Clinical Trial Agreement (CTA) and Budget agreements.
FDA Rapid Response Team
- Prepare for FDA inspections through on-site review of charts and regulatory documents as well as assist with responding to FDA 483s, including Corrective and Preventative Action Plans.
Aventiv Research prides itself on the work and data that they are known to deliver. Let us help you in becoming a leading site in the world of research. Please fill out the form below to get started.