Clinical trial timeline standards
How long do most CROs take to lock a database? What turnaround should you expect for TLFs? We’re sharing average timelines and our own standards to help sponsors evaluate their biometrics CROs.
The PharPoint team is certified in two leading EDC platforms and has experience in 15+ others, enabling us to build databases efficiently while keeping your end goals in mind. We involve biostatisticians early, ensuring data collection is designed meaningfully – keeping in mind both input and output. The industry average for database builds, according to a 2017 Tufts Center for the Study of Drug Development (CSDD) report that was re-confirmed in 2021, is 68 days. PharPoint is able to build and release most databases within 6 weeks.
average
30 days
INDUSTRY average
68 days
PharPoint’s team is able to produce faster mid-study database changes when needed, with small changes taking as little as 1-2 business days. Longer, more complex changes typically take 1-2 weeks, depending on sponsor needs. This can be compared to a spring 2021 Tufts CSDD report, which found that on average, both planned and unplanned mid-study database changes take approximately 30 days.
AS FEW AS
1-2 days
INDUSTRY average
30 days
When it comes to faster database lock, planning is everything. PharPoint uses a variety of tools, including comprehensive data management plans, a well-designed database, input from cross-functional stakeholders, and meaningfully written edit checks to allow for cleaner, faster data. Our team uses ongoing data cleaning, keeping your study top of mind and addressing issues and queries on an ongoing basis. We regularly interact with stakeholders, and ensure data issues are addressed with sites while that site is still engaged. The result? Database lock just five days after final source document verification.
AS FEW AS
5 days
INDUSTRY average
35 days
Top line results are always highly anticipated, and our team works to get them to you as fast as possible without sacrificing quality. To do this, our statisticians engage in the programming progress soon after the Statistical Analysis Plan (SAP) – containing mock Tables, Listings, and Figures as well as Analysis Database Specifications – is in a “near final draft”. Additionally, we utilize ongoing verification prior to data lock to accelerate the deliverable process flow.
average
2 days
INDUSTRY average
5 days
From receipt of Final TLFs to the delivery of a final CSR, what kind of timeline should you expect from your medical writer? We’ve pitted our medical writing team’s standard timeline against the industry average, as reported by cumulative data from 2008 through 2013. CSR delivery includes a draft document along with two review cycles. And Sponsor, beware: while 49 days was the industry average, the report found incredibly wide-ranging results!
40 days
INDUSTRY average
49+ days
“…High priority pivotal studies locked and delivered faster than any other CRO I have worked with in my experience. Not only was the study delivered within budget and early, it was a quality deliverable.”
VP CLINICAL OPERATIONS, BIOTECHNOLOGY CLIENT
