Contract Research Organization
Contract Research Organization
Project development, start-up, and project management services for Phase I-IV FDA, non-FDA, drug, device and biologic studies.
Concept and Strategy Development
Clinical trials are only as good as their design. In order to achieve successful execution, the design of the trial must be strategically planned. ARA can save you time and money through our creative and collective approach.
Protocol Development
Elaborate description of the synopsis, literature background, objective(s), endpoints, design, methodology, statistical considerations, organization, and workflow of the study.
Budget Estimation
Develop budget for proper cost allocations to ensure the clinical trial has required resources to cover the life cycle of the study.
Essential Study Documents
Provide the Investigator’s Brochure, Informed Consent Forms, Case Report Forms, Recruitment and Advertisement materials.
Site Selection, Feasibility, Qualification
Identify and provide qualified clinical research sites.
Budget Negotiations
Expertise in negotiating the best budget for you.
Legal Consulting
Negotiate clinical research agreements with the client’s best interest in mind. Expertise in applicable regulations, relevant policies and guidelines.
IRB Support and Submissions
Provide assistance for the submission, review and approval processes, handling inquiries and appeals if needed.
Healthcare Compliance
Observance with federal and state laws/guidelines to protect personal information of patients and staff. Compliance with the Anti-Kickback Statute and the Physician Payments Sunshine Act.
Statistics
ARA has expert statisticians on our team to support a variety of statistical modeling and analysis.
Regulatory Consulting and Submissions
ARA consists of an expert team who knows the FDA, EU MDR, HIPAA and CMS regulations, and ICH-GCP E6 (R2) guidelines.
Study Monitoring
Provide experienced monitors/ CRAs to visit sites and conduct a thorough review and investigation of all study participants- ensuring site investigators, coordinators, and other study staff are in compliance with protocol, regulations, policies and guidelines.
Study Closeouts
Final audit of regulatory and subject files. Final source data verification. Test article inventory reconciliation, quality assurance and assist with FDA audit. Requirements for data retention and storage.
Electronic Data Capture and CTMS Customization and Support
Provide a secure master database customize to study needs for data collection, tracking, organization and reporting.
Liaison for Ancillary Services
Our resources allow us access to ancillary service such as Radiographs, MRIs, Ultrasound, Electrocardiograms, lab work, physical therapy, home visits, and more.