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Advancing Maturity of Clinical Protocol Template Helps Reduce Protocol Development by 21%


“We implemented the “Clinical Protocol Template (CPT)” across all interventional clinical studies at our member company. Using this template, our company has saved 168 hours in protocol development time (i.e., cycle time/effort from receipt of a governance-approved core protocol—pre-cursor to the protocol—to protocol approval). The decrease in time and effort has yielded several positive impacts. The efficiency gain has enabled study teams to develop high-quality, streamlined clinical study protocols in less time. The CPT has also reduced rework which has resulted in fewer amendments. From 2019 to 2020, we have determined that continued maturity of CPT use has resulted in a 20.8% average decrease in cycle time/effort. The continued implementation of the CPT across new studies has helped us tremendously in our pursuit to bring vital drugs to patients faster.”

Data Breakdown from 2019-20 Use of Clinical Protocol Template

Number of Protocols*33
Maximum number of days5737
Minimum number of days4126
Average cycle time/effort from Core Protocol receipt to Protocol approval
(in days)
Percent reduction in cycle time/effort20.8%