SERVICES

Building on research hospital and pharmaceutical industry experience, we have developed a successful independent consultancy. Since forming DSMS, we have provided professional services to investigational sites, pharmaceutical and medical device companies. Our services include:

• Site Assessment:
Evaluation of research sites pre-study to assure resources, facilities, equipment, staff qualifications and experience are appropriate for contemplated studies.

• Monitoring:
Site monitoring (including initiation and close-out) for pharmaceutical and medical device studies. We provide research sites with guidance and mentor them in all aspects of clinical trial management. We ensure compliance with Health Canada guidelines and FDA regulations regarding investigational test articles, adequate study record files and completion of case report forms. Where studies will cross international boundaries, we assure compliance with ICH guidelines.

• Audit Preparation
DSMS works with investigational sites to review study procedures and activities for adherence to applicable requirements and/or guidelines (i.e., FDA and ICH), site-specific SOPs, where applicable, and study protocol. Our services include assessing Good Clinical Practice (GCP) documentation for compliance with current site SOPs (i.e. documentation related to the Informed Consent process). We recommend corrective actions and assist sites in implementing these, as necessary.

• Training.
DSMS provides professional development programs, including ICH GCP orientation and training and FDA Regulatory training. We have extensive experience in developing and facilitating seminars and workshops aimed at the clinical research professional. Since 2002, Helen Darwin is a course leader and presenter for numerous continuing education programs throughout Canada and the United States. Many of these courses are held in conjunction with SoCRA – The Society of Clinical Research Associates.