Solving Data Management Challenges with Strategic CRO Oversight

Sponsors occasionally face unexpected hurdles with their data management vendors —missed timelines, inconsistent data quality, and inefficient workflows.

These challenges can delay critical milestones like database lock and compromise the integrity of clinical trial data.

In a recent analysis of clinical trial costs conducted by Tufts CSDD, a Phase III clinical trial spends, on average, $55,716 per day in direct costs. When issues are identified early, sponsors can get vendors back on track and back on time through data management CRO oversight, potentially saving hundreds of thousands of dollars in costs due solely to inefficient operational strategies.

We spoke with a PharPoint Data Management consultant who regularly partners with sponsors to provide this oversight, and she discussed three common findings.

One

Your data management CRO isn’t fully leveraging technology.

One common challenge is an over-reliance on manual processes for data cleaning. Manual review can introduce inefficiencies and increase the risk of errors, as humans are naturally prone to oversight.

At PharPoint, most of our data cleaning tasks are supported by SAS programming. This allows for faster, higher-quality processing of large datasets and reduces the risk of human error.

Another contributing factor to poor technology adoption can be insufficient training for data coordinators. Without exposure to advanced tools or techniques – such as SAS or enhanced Excel functionality – team members may not realize what is possible beyond manual review. Comprehensive training and a collaborative team can help bridge this gap.

Two

Your data management CRO is waiting until database lock to conduct 90% of the data cleaning.

Another key observation is the tendency of data management teams to lag behind in data cleaning efforts until the database lock stage. When the majority of cleaning happens at the end of a study, it creates bottlenecks for all stakeholders — data managers, CRAs, and site staff.

Early and ongoing cleaning throughout the study lifecycle helps maintain data quality, reduces last-minute surprises, and ensures a smoother path to database lock. Ultimately, this approach helps teams supports timely deliverables with the highest data quality, whether for interim analyses, regulatory submission requirements or final database lock.

Three

Your data management CRO doesn’t collaborate with their biostatistics team.

Data Management and Biostatistics often operate as separate functions, yet their work is highly interconnected. Early collaboration with biostatisticians can provide data managers with valuable context and prevent downstream challenges post-database lock.

In one recent example of this cross-functional teamwork in action, the PharPoint data management team was determining how to best report a complex screen failure situation. The team held discussions with the biostatistician to help brainstorm, who was able to inform on which potential data entry solutions under consideration would impact final analysis outputs. What the data management team was considering as the leading option was ultimately decided against with the input from the biostatistical perspective.

This type of casual collaboration and integration across functions helps data managers proactively make informed decisions while keeping statistical endpoints in mind.

Partnering for Better Outcomes

There are many reasons why a sponsor may choose to engage a Data Management CRO Oversight partner, from addressing technology gaps to ensuring consistent quality and operational efficiency.

Regardless of current concerns, sponsors do not have to navigate these challenges alone. PharPoint’s data management consultants provide strategic oversight, guidance, and plans to help strengthen vendor performance, improve data currency, and accelerate timelines.

To learn more about our data management CRO oversight support solutions, reach out to our team.


RELATED RESOURCES

Database Build: Our Standard Timeline from Final Protocol to Database Go-Live

Database Build: Our Standard Timeline from Final Protocol to Database Go-Live

How long does it take to go from final protocol to database go-live?
Examining Strategies for Faster Clinical Study Report Timelines

Examining Strategies for Faster Clinical Study Report Timelines

Examining Strategies for Faster Clinical Study Report Timelines How long does it take a medical writer to produce a high-quality clinical study report (CSR)? What can a medical writer do to help speed up this turnaround without sacrificing quality? Biopharma companies are under increased pressure to reduce timelines, yet this acceleration cannot come at the expense of accuracy or regulatory compliance. JUMP TO: What is the standard timeline for CSR delivery? Strategies to accelerate CSR timelines responsibly Multiple writers QC processes Peer review Draft data We spoke with PharPoint’s Associate Director of Medical Writing, Samia Khader, to discuss her thoughts on potential strategies for the faster delivery of a final CSR. Evaluating the standard timeline for CSR delivery CSR timelines can vary greatly depending on a range of factors which are not all under a medical writer’s control. That said, according the American Medical Writers Association, a common timeline for the delivery of a CSR is about 52-60 working days. At PharPoint, our typical timeline from receipt of final Tables, Listings, and Figures (TLFs) to the delivery of a final CSR is 40 business days. This includes two rounds of review, with drafts reviewed by Sponsors within five business days. PharPoint Standard CSR Timeline What strategies might a medical writer use to accelerate CSR timelines responsibly? Responsible acceleration of the CSR timeline requires deliberate process choices that can improve coordination and reduce inefficiencies while protecting quality and compliance of the final deliverable. In the sections below, we outline several ways that a medical writer might help move a CSR forward, along with a verdict on each approach and the conditions where it makes sense (or does not). Using multiple writers There are circumstances where using multiple medical writers might provide meaningful acceleration, however, strategic planning and coordination is required for
Solving Data Management Challenges with Strategic CRO Oversight

Solving Data Management Challenges with Strategic CRO Oversight

Explore three common findings from a data management consultant who has experience performing DM CRO oversight.
Achieving Expedited Database Lock with Director of DM, Wendy Moffett

Achieving Expedited Database Lock with Director of DM, Wendy Moffett

Director of Data Management Wendy Moffett discusses how PharPoint achieves rapid database lock in this short video.
A Guide to Reviewing Regulatory Documents as a Subject Matter Expert (SME)

A Guide to Reviewing Regulatory Documents as a Subject Matter Expert (SME)

We discuss best practices to allow a reviewer to effectively and efficiently provide critical input to regulatory documents.
Four Signs It is Time to Break Up with Your Regulatory Medical Writing Vendor

Four Signs It is Time to Break Up with Your Regulatory Medical Writing Vendor

Explore some of the standards should you expect from your regulatory medical writing partner.
Written by: Theresa Hegar