Clinical Trials Management

Whether you're looking for limited support or full-scale project development, CROfessionals is always willing to meet your individual research needs, with a comprehensive service menu that includes:

Medical writing

Our clinical team combines specialized knowledge with operational know-how to establish a clinical research setting where patient well-being is paramount and dependable results, a given. Using a team approach, we provide centralized project management; 24/7 safety support; continuous training and professional development; and, above all, absolute accountability, every step of the way.

The end result: a rapid-response service delivery system that is exceedingly reliable, flexible, and cost-effective.

Regulatory Services and Support

With product development oversight more stringent than ever, regulatory expertise is critical to success. That's why at CROfessionals, we are especially proud of our recently expanded regulatory group - under the capable leadership of Company President & Clinical Director Sue Bhadare, who works closely with the team.

From sound advice to practical solutions, our team provides you with the help you need to design initial protocols; develop and implement regulatory strategies; prepare and submit regulatory applications; and facilitate agency communication.

Well-versed in U.S., Canadian, and European regulatory submission procedures, CROfessionals offers solid strategic input, along with hands-on support, in preparing pre-IND/IDE, IND/IDE, and CTAs; as well as BLA, 510(k)/PMA, and NDA applications. We then carefully review these submissions to ensure that they are properly completed in accordance with appropriate regulatory guidelines. CROfessionals is also available to help you create presentations for, and accompany you to, meetings with relevant regulatory organizations.

Quality Compliance and Audits

At CROfessionals, quality assurance that is both consistent and meticulous forms the foundation of our business process. From the very beginning, our quality assurance team is on hand to ensure our CROfessionals Standard Operating Procedures are followed and written in accordance with CFR/EU Directives and ICH guidelines. We develop a quality assurance plan for each study, which details audit scope, content, and timelines.

Our QA auditors regularly review site data, regulatory documents, and other aspects of your study, providing you with ongoing audit reports, and recommendations for corrective and preventive actions, as needed. They also ensure that trial protocols are both understood and closely followed. Moreover, we audit ourselves carefully and continuously across all functions and throughout the life cycle of each study we conduct.