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Services and support we Provide

IND Submission Services

Pre IND Meeting Process – Meeting Request and Background Preparation, Submission, and FDA Coordination

IND Sponsor Investigators can learn about the soundness of study design and study acceptability from a Pre-IND consultation with the FDA. Through the Pre-IND consultation program, potential IND holders can consult with the FDA to discuss preclinical studies needed to support clinical testing, understand study product chemistry, manufacturing and control (CMC) issues, and to preview the proposed clinical study.

Initial IND Application – Application Preparation, Submission, and FDA Coordination

Required information includes:

  • Complete protocol and study documents
  • Informed consent form
  • List of all investigators and sub-investigators and a Curriculum Vitae for each investigator listed
  • List of all study locations
  • List of all clinical laboratories
  • Study drug Investigator Brochure, or product package insert
  • Pharmacy Manual (if applicable)
  • Response to FDA PIND comments
  • Letter authorizing IND or NDA cross reference for study drug ( if applicable)
  • Principal Investigator signature on FDA regulatory forms and cover letter

Address Post IND Requirements

  • Internal and external audit assistance
  • Coordinate communication
  • Amendment preparation and submission
  • Adverse event reporting
  • Annual report preparation and submission
  • File Study completion or termination

IDE Submission Services

Pre Sub Meeting Process – Pre Sub Meeting Preparation, Submission, and FDA Coordination

IDE Sponsor Investigators can utilize early communication with the Office of Device Evaluation (ODE) through an IDE Pre Sub meeting, which is a valuable resource for sponsor investigators and studies with new technology. This meeting increases the understanding of FDA requirements for IDE studies and applications and decreases delays in the submission process.

Initial IDE Application – Application Preparation, Submission, and FDA Coordination

Required information includes:

  • Statement that the information provided is an original IDE submission.
  • Device Information:
    • Device Name
    • Intended Use
    • Thorough description of medical device
  • Sponsor contact information
  • Manufacturer Information
  • Complete protocol and study documents
  • Informed consent form
  • Pre-Submission meeting information and response to FDA comments.
  • Principal Investigator signature on FDA regulatory forms and cover letter

Address Post IDE Requirements

  • Response to FDA IDE conditions
  • Internal and external audit assistance
  • Coordinate communication
  • Amendment preparation and submission
  • Adverse event reporting
  • Annual report preparation and submission
  • File study completion or termination

Drug or Biologic Expanded Access Services (Including Emergency Use Applications)

Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational drug or biologic for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Expanded access pathways include: 

  • Expanded access for individual patients, including for emergency use
  • Expanded access for intermediate-size patient groups
  • Expanded access for widespread treatment use

Expanded Access Application – Application Preparation, Submission, and FDA Coordination

  • Description of the patient’s condition and circumstances necessitating treatment
  • Discussion of why alternative therapies are unsatisfactory
  • Complete Treatment Plan (Template available on request for assistance)
  • Informed Consent Form
  • Investigator Brochure
  • Letter of Authorization from the drug manufacturer
  • Physician Signature on FDA regulatory forms and cover letter

Address Post Submission Requirements

  • Internal and external audit assistance
  • Coordinate communication
  • Amendment preparation and submission
  • Adverse event reporting
  • Annual report preparation and submission
  • File Study completion or termination
  • Maintain Regulatory Files

Device Expanded Access Services

Expanded access is a potential pathway for patients with a serious or life-threatening disease or condition to access an investigational medical device that has not been approved or cleared by the FDA for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available through one of three mechanisms:

Initial Application – Application Preparation, Submission, and FDA Coordination

Required information includes:

  • A description of the patient's condition and the circumstances necessitating treatment
  • A discussion of why alternative therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.
  • The patient protection measures that will be followed
  • A draft of the informed consent document that will be used
  • Clearance from the institution as specified by their policies
  • Concurrence of the IRB chairperson
  • An independent assessment from an uninvolved physician
  • Authorization from the device manufacturer on the use of the device.
  • Physician signature on FDA regulatory forms and cover letter
  • Additional information may be requested as required

Address Post Submission Requirements:

  • Response to FDA comments
  • Internal and external audit assistance
  • Coordinate communication
  • Amendment preparation and submission
  • Adverse event reporting
  • Annual report preparation and submission
  • File treatment completion or termination
  • Maintain Regulatory Files

Maintain Regulatory Files