Physician/Investigator

Thank you for your interest in being considered for inclusion in our ever growing network of highly qualified and enthusiastic clinical investigators. As the customers we serve demand highly capable and qualified Investigators, so must we ensure that those physicians we work with exhibit those criteria. Below are some basic minimal requirements we require in those Investigators and Sites seeking to participate in our network.

Investigator Requirements

• PI must have minimum of 3, preferably 5, previous study experiences within last 3-5 years which is documented by a CV not older than 3 months and has been signed/dated by PI attesting to its accuracy.
• An amendment to the CV must be included which outlines previous study experience to include:
  1. Study Indication
  2. Dates of participation
  3. Enrollment goal
  4. Number of patients enrolled
• PI must be Board Certified in his/her area of specialty - Board Eligible physicians please contact us to discuss.
• PI must not have been debarred or currently under investigation by FDA or any medical licensure board or have any limitations placed on his/her ability to practice medicine.
• Understands the role and responsibilities of a PI and is willing to undertake such responsibilities (provided by SMO-USA, Inc.) as well as a working knowledge of Good Clinical Practices.
• If PI or study site has been audited by the FDA, a copy of FDA Form 483 must be provided. This is for internal purposes only.

Physical/Site Requirements

• Prefer dedicated exam rooms.
• Locked and limited access drug and supply storage facilities.
• Basic lab and equipment facilities for specimen and diagnostic collection. All lab and equipment facilities must be calibrated and certified as required by law.
• Refrigeration and freezer capabilities or accessibility specific to the needs of the study drug.
• Prefer a dedicated area for storage of study binders that has limited access and is secure.
• Dedicated area for monitor visits that is well lighted and comfortable (limited noise and traffic).
• Maintain a system for quickly identifying patients by diagnosis or condition.
• Accessibility to sub specialties that sometimes are necessary for specific studies.

In an effort to better understand your qualifications, capabilities and interests, we ask that you fully complete and submit the Investigator Enrollment and Database Form. Upon our receipt and evaluation of this information, we will follow up with you to discuss your inclusion in our network. Thank you and we look forward to developing a mutually beneficial working relationship with you. Should you have any questions, please feel free to contact us.

The Investigator Enrollment and Database Form is also provided in Adobe's Portable Document Format (PDF). To view these documents, you will need Adobe Acrobat Reader, if you do not have it, follow the link below to download a copy.