Trial Design and Protocol Planning

Ensure quality by design with WCG’s 360 Protocol Assessment™ – an integrated, turn-key solution that improves clinical trial predictability by providing sponsors with an operational risk and feasibility assessment of the protocol through the lens of multi-functional stakeholders.

Decrease the number of required protocol amendments by highlighting key risks during the planning phase of the trial with WCG’s holistic review.

According to the Tufts Center for the Study of Drug Development, 57% of protocols had at least one substantial amendment, and nearly half (45%) of those amendments were deemed “avoidable”. Similarly, protocols with at least one substantial amendment have fewer actual screened and enrolled patients.

WCG’s 360 Protocol Assessment™ addresses ICH E8 R1 expectations and improves clinical trial predictability by providing sponsors with an operational risk and feasibility assessment of the protocol by representing all industry stakeholders.

Our subject matter experts identify risks and provide mitigation strategies.

Meet regulatory expectations and enable faster, more efficient, higher-quality clinical trials.

Embed Predictability

  • Avoid untimely protocol amendments, penalties, and delays to clinical trial timelines
  • Reduce uncertainty in study-start up activities – from protocol development to site selection

Pressure Test Protocols

  • Evaluate operational risk to the sponsor and feasibility of the protocol from the beginning
  • Be proactive in diversity and inclusion planning from the earliest stages of protocol design

Mitigate Risk through Data Intelligence

  • Assess the competitive landscape for site selection
  • Drive enterprise-level decision-making through robust data and insights

Contact us to schedule protocol development support or review with our experts.

How we help you achieve your goals

WCG’s 360 Protocol Assessment™ incorporates strategies to proactively mitigate or manage the identified risks for faster, less costly clinical trial execution.

As a result, sponsors can:


Identify areas of risk and clarity as well as corresponding mitigations that can be addressed in the planning phase.


Reduce uncertainty in clinical trial execution.


Drive enterprise-level decision-making through a thorough risk assessment to achieve higher quality trials and better outcomes.


Take a more proactive approach to diversity and inclusion planning that begins at the earliest stages of protocol design, long before recruitment planning.


Benchmark their protocol against the current competitive landscape in the market.

Maximize your investment: schedule a trial design and protocol planning consultation

When you have our experts review your protocol, the early investment ensures your study—and overall investment—meets its full potential. To start, simply fill out the form.