Services to clinical research sites

High quality professional support

We provide consulting and assistance to clinical research sites

• Source Document Preparation: We prepare source documents applying the principles of Good Clinical Practices and ALCOA+.

• Regulatory Document Review and Preparation: We assist in the preparation of regulatory documents prior to the initiation of the study as well as in maintaining them during the conduct of a study.

• SOP Creation: We provide a package of standard procedures tailored to the needs of the site.

• Start-Up Assistance: We help prepare the site and staff members prior to the initiation visit.

• Subject Recruitment Assistance includes Site Database. We assist in recruitment strategies according to the characteristics of the site and the study. We offer an application to create the site's patient database.

• Quality Control: We assist in quality control. We review source and regulatory documents; study medication, its chain of control and accounting.

• Audit Preparation: We assist in preparing for sponsor or FDA audits.