Hope Research Consulting LLC
H.O.P.E Research Consultants team will help guide you through the process of becoming a successful clinical research site. 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, as your clinical trials consultants the mutual goal is to make a positive difference in the Community – by substantiating safety, quality, and/or efficacy.
Our Clinical Trial Consulting Services include:
New Site Start-Up
Initiate and oversee research activities within private practices; conduct initial site set up, business development outreach, assist in staffing for conduction and oversight of trials, and provide necessary training to new investigators and ancillary staff as needed.
Site Engagement and Management
Provide guidance on site selection – including preparation of detailed questionnaires – and oversight in adherence with company guidelines. Assistance with Clinical Trial Agreement (CTA), budget and contract negotiations, marketing & recruitment Strategies.
Standard Operating Procedures
Help with the creation, modification, and implementation of site or company-specific Standard Operating Procedures (SOPs).
Establish Budget and Timelines
Clinical trials can be costly and time-consuming; our team will work to ensure you stay within your clinical research budget and remain constantly aware of transparent timelines throughout the whole process.
Develop a Strategy
Our team will work with you to identify the best possible approach to become successful in capturing what best fits the need of a site through tactfully selected clinical trials.
Operations and Staffing
Our team will Consult on staffing and infrastructure to provide recommendations on current 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.
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.
Site Close-Out Procedure/Process
Trial close-out is the act of ensuring that all activities related to the clinical trial are appropriately reconciled, recorded, and reported at the end of the trial. Our team is entrusted with the responsibility of ensuring close-out related visits and activities. It is conducted in accordance with the protocol, relevant SOPs, and applicable regulatory and GCP guidelines. In most instances, the trial is considered closed after the finalization of clinical study report post database lock.
H.O.P.E Research Consultants prides itself on the work and data that they are known to deliver. Our staff have the expertise to help you conduct and manage clinical trials for drugs and medical devices. Whether you need assistance from the beginning to the end of a trial, our clinical operations experts are here to provide support. Let us help you in becoming a site in the world of research. Contact our experts today to learn more about to get started.