Bob Michalik has significant "hands on" experience in the planning, implementation, management, evaluation and analysis of clinical studies to meet overall project and departmental objectives.    Rely on RegulatoryPro to ensure your clinical program is executed in accordance with Good Clinical Practices (GCP) guidelines and regulatory requirements.

Specific services offered include:

• assistance in the development of compliant, yet flexible clinical protocols, amendments and Case Report Forms, and company policies and procedures to provide the necessary legal and regulatory protection throughout the course of  your clinical investigations

• development of site initiation training materials/study management tools and coordinating clinical site training meetings (protocol review, study conduct, GCP guidelines and regulations

• project management oversight of clinical investigative teams  to ensure domestic and international regulatory compliance, clinical data integrity, source document verification and timely resolution of clinical study deficiencies.

• overseeing database closure activities and preparation of the clinical study report.