At Sterling IRB, we provide expert guidance and personalized service for the unique needs of your clinical trial. With a sole focus on delivering efficient, high-quality IRB services, Sterling IRB equips you with the expertise and support needed to accelerate your research to market.

We serve biopharmaceutical companies, CROs, investigators, and institutions involved in research in a wide variety of therapeutic areas, medical devices, biologic, and diagnostic trials.

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  • Central and local IRB services
  • Comprehensive review services in U.S. and Canada
  • Experienced and diverse board
  • Daily board meetings
  • Pre-review services for protocols
  • Informed consent (eConsent) in research development
  • Certified translation services
  • IRB review of research involving all vulnerable populations, including prisoners, cognitively impaired persons, pregnant women, and children
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  • Dedicated CIP certified account manager for study duration
  • Study startup teleconferences upon request
  • Timely turnaround
    • Two-business day average turnaround time (expedited IRB review) from date of submission
    • Five-business day average turnaround time (full board IRB review) from date of submission
    • Written notification within 24 hours of IRB Meeting
    • Site review within 24 hours
  • Site startup status reports and continuing reports according to your requirements
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  • Phase I-IV studies in all therapeutic areas
  • Single and multisite studies
  • Federally funded studies
  • Late-phase studies – post-market, observational, risk evaluation and mitigation strategies (REMS), registries
  • Medical device studies
  • Biologic studies
  • Gene therapy studies (including those requiring IBC services)
  • Fully and partially decentralized clinical studies
  • Nutraceutical studies
  • Social-behavioral studies
  • Minimal risk/non-interventional studies
  • Exemptions
  • Nonhuman subject research and ethical evaluations
  • Knowledge, attitudes, and beliefs (KABs)

Regulatory Services

  • Protocol pre-review, including consultations with FDA Policy Analysts on project specific matters
  • Research of FDA’s Good Clinical Practice Program statements, FDA guidances, and FDA regulations
  • Remediation or mitigation measures for matters of noncompliance or unanticipated problems involving risks
  • Communication of reportable findings to regulatory bodies
  • Safeguards for vulnerable subject populations
  • Measures to promote subject and data retention
  • Training for research investigators, staff, and sponsors

Review Timelines

Notification of Approvals and Acknowledgements

Federal regulations recognize that certain aspects of research may be reviewed by an IRB through an expedited review procedure. Sterling IRB employs the expedited review procedure for minor changes in previously approved research during the period (of one year or less) for which approval is authorized, and for initial review of studies in permissible categories as detailed in the Federal Register.

Human subject research studies that are not classified as exempt and that are not eligible for expedited review require review by the full board at a convened meeting. Sterling IRB convenes daily meetings (Monday-Friday). Submission deadlines are five business days prior to the scheduled board meeting for the submission of new protocols and three business days for amendments to previously approved protocols and all other items requiring full board review.

Submission Type Route of Review Review Turnaround Time Documents Issued
New Study

Full Board Review or Expedited Review

New study submissions reviewed via expedited review have a 2 business day turnaround time on average. New studies reviewed via full Board review have a 5 business day turnaround time on average.

*Usually sent within 2 business days of approval

*Notification made within 24 hours of review.

Modification / Amendment to a Previously Approved Study Protocol/Consent

Full Board Review or Expedited Review

Usually reviewed within 48 hours of receipt of a complete submission

**Usually sent within 2 business days of approval

**Notification made within 24 hours of review.

New Principal Investigator (or Change in Principal Investigator)

Full Board Review or Expedited Review

Review within 24 hours of receipt of a complete submission

Usually sent within 2 business days of approval

Recruitment Materials and Other Submission Items That Qualify for Expedited Review (Including Most Sponsor-Granted Exceptions)

Expedited Review

Usually reviewed within 24 hours of receipt of a complete submission

Usually sent within 2 business days of approval

Continuing Review of Study/Site

Full board review or expedited review if eligible

The study and continuing investigative sites are reviewed as one entity at time of continuing review. Review usually occurs within 2-4 meetings prior to the study expiration date.

Usually sent within 2 business days of approval

Serious Adverse Event, Significant Protocol Deviation and Unanticipated Problem Reports

Primary Reviewer reviews and designates for non-Board Acknowledgment or Full Board Review

Usually reviewed within 1-2 weeks from date of receipt of a complete submission

Acknowledgments usually sent within 1 week from date of review

External Adverse Events (INDs)

IND reports are acknowledged unless submitted as potential unanticipated problems involving risks to subjects or others

Usually acknowledged within 1-2 weeks from date of receipt of a complete submission

Acknowledgments usually sent semi-monthly

Site Final Reports

Expedited Review (most qualify for this route of review)

Usually reviewed within 2 business days from date of receipt of a complete submission

Usually sent within 2 business days of approval

Submission Type
New Study
Route of Review

Full Board Review or Expedited Review

Review Turnaround Time

New study submissions reviewed via expedited review have a 2 business day turnaround time on average. New studies reviewed via full Board review have a 5 business day turnaround time on average.

Documents Issued

*Usually sent within 2 business days of approval

*Notification made within 24 hours of review.

Submission Type
Modification / Amendment to a Previously Approved Study Protocol/Consent
Route of Review

Full Board Review or Expedited Review

Review Turnaround Time

Usually reviewed within 48 hours of receipt of a complete submission

Documents Issued

**Usually sent within 2 business days of approval

**Notification made within 24 hours of review.

Submission Type
New Principal Investigator (or Change in Principal Investigator)
Route of Review

Full Board Review or Expedited Review

Review Turnaround Time

Review within 24 hours of receipt of a complete submission

Documents Issued

Usually sent within 2 business days of approval

Submission Type
Recruitment Materials and Other Submission Items That Qualify for Expedited Review (Including Most Sponsor-Granted Exceptions)
Route of Review

Expedited Review

Review Turnaround Time

Usually reviewed within 24 hours of receipt of a complete submission

Documents Issued

Usually sent within 2 business days of approval

Submission Type
Continuing Review of Study/Site
Route of Review

Full board review or expedited review if eligible

Review Turnaround Time

The study and continuing investigative sites are reviewed as one entity at time of continuing review. Review usually occurs within 2-4 meetings prior to the study expiration date.

Documents Issued

Usually sent within 2 business days of approval

Submission Type
Serious Adverse Event, Significant Protocol Deviation and Unanticipated Problem Reports
Route of Review

Primary Reviewer reviews and designates for non-Board Acknowledgment or Full Board Review

Review Turnaround Time

Usually reviewed within 1-2 weeks from date of receipt of a complete submission

Documents Issued

Acknowledgments usually sent within 1 week from date of review

Submission Type
External Adverse Events (INDs)
Route of Review

IND reports are acknowledged unless submitted as potential unanticipated problems involving risks to subjects or others

Review Turnaround Time

Usually acknowledged within 1-2 weeks from date of receipt of a complete submission

Documents Issued

Acknowledgments usually sent semi-monthly

Submission Type
Site Final Reports
Route of Review

Expedited Review (most qualify for this route of review)

Review Turnaround Time

Usually reviewed within 2 business days from date of receipt of a complete submission

Documents Issued

Usually sent within 2 business days of approval

Please note: Review turnaround times for most items received after study approval are from the date of receipt of a complete submission. The Sterling IRB administrative staff works closely with clients to meet deadlines, particularly those that do not fall within the usual study submission timeline. Our staff makes every effort to resolve any questions or concerns prior to the board’s or primary reviewer’s consideration to ensure a timely review process.

When you need focused, full-service IRB solutions, Sterling IRB is dedicated to you.

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