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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.