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Protocol Optimization Services

Maximize Value and Efficiency While Minimizing Associated Burden and Costs of Clinical Trials


Pharm-Olam is focused on supporting our Sponsors' achievement of rapid drug development through clinical trial and study design optimization to therefore maximize study value while delivering quality clinical studies that protect patient safety. 

Our Protocol Optimization Services will help you optimize patient and site activities while balancing all study complexities to deliver the most beneficial, cost-effective and lean study design possible.

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45% of protocol amendments are avoidable and 59% of clinical trials have at least one protocol amendment 

Source - 2017 Tufts CSDD Article

Protocol Optimization = Study Optimization

Overview of Service Benefits: Clinical trial protocol optimization works to enhance study design via benchmarking procedural selection as well as frequency of study activities. 

Consulting services focused on the identification of protocol optimization opportunities to enhance study value while managing costs
Leveraging a proprietary dataset spanning thousands of study designs and phases which allows benchmarking and identification of optimization opportunities for consideration
Evaluation of your study design for potential enhancements to study efficiency, reduction of patient or site burden, and objectivity
Streamline your protocol and maximize a study's value within your development program - where every patient matters and every day counts in clinical research
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Supported Therapeutic Area Optimizations

Pharm-Olam presently supports Protocol Optimization for the following therapeutic areas:

  • Allergy
  • Autoimmune
  • Hematology
  • Infectious Disease
  • Oncology
  • Rare Disease - Indication dependent
  • And more...


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Clinical Trial & Protocol Optimization - Process Overview

*Please note: Pharm-Olam can provide protocol writing services, but this is not built into standard protocol optimization services. Please speak with our team if this service is needed.

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Gain Insight into Investigator Grants

As part of our Protocol Optimization Service, we will run three Investigator Grant analysis scenarios on your behalf, leveraging Medidata's Rave Grants Manager

  1. Analysis of your initial investigator grants based on your current study design
  2. Analysis of investigator grants with all optimization opportunities incorporated
  3. Final analysis of investigator grants with agreed optimization opportunities incorporated
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I'm Interested! What's Next?

First, complete the form below and our team will reach out in under 24 hours to set-up a brief introductory conversation.  We will need information about your study to determine whether we can compare it against other similar trials, so you will want a confidentiality agreement executed (we can use your CDA template or ours).  Then we will need your study design details to determine if and how we can move forward to support your clinical study. 

We are dedicated to helping you create a healthier world.  Pharm-Olam goes the distance.  

Looking to optimize your protocol design?

Talk to our team today.