Case Study No. 3

Improving Data Cleaning Timelines
for Pivotal Studies

I. Situation:  

Highline Sciences was selected by a mid-size, oncology biotech company for a pivotal program designed with the intention of receiving breakthrough therapy designation from the FDA. The Sponsor was seeking a CRO partner with professionally-mature, field-based monitors capable of building supportive site relationships and delivering clean data required for rolling FDA data submissions.

II. Challenges:  

Complex trial with high data volume. Breakthrough therapy designation was received and rolling data submissions began 12 months ahead of the final data deliverable.

Maintaining site relationships, enthusiasm and compliance despite constant pressure for data entry and query resolution. Data snapshots were completed every 2 months for one full year. Highline was tasked with compressing timelines from data cutoff to data snapshot.

III. Strategy:  

The Highline Clinical Operations team deployed a monitoring team with an average of 17 years of monitoring experience (focused in oncology) and established site relationships. These monitors focused on building supportive relationships, adding value and thinking strategically versus box-checking and adding to the site burden.

The team clearly communicated data entry and review goals early in the trial while communicating priorities and helping site staff manage their workload. Clear KPIs and escalation plans were established with centralized oversight via heat maps and programmed reports to identify high-risk sites early.

IV. Results:  

The combination of team and strategy from Highline allowed this Sponsor to maintain data entry over 90% and source data verification over 85% from study start to closeout. Timelines from data cutoff to data snapshot were compressed for each of the rolling data submissions and allowed the Sponsor to submit the final NDA months ahead of schedule.

The positive site relationships established during this trial were crucial. Clinical sites have so many competing priorities in this competitive oncology clinical trial environment and it is clear that site staff will prioritize their efforts to projects where they have the most support.

“Compared with other CROs, I really saw a difference during preparations for our interim analyses. Highline understands what’s important from a sponsor’s side. Their CRAs are committed to getting the data in with queries resolved on time.”
—Oncology Biotech