Case study · Healthcare & Life Sciences

Global clinical trial data harmonization for an oncology pipeline

A top-10 pharmaceutical company running a Phase III oncology trial across 12 countries saw fragmented SAS reporting standards threaten its FDA submission window. ApTask stood up a follow-the-sun SAS and clinical data team under a fixed SOW; two years of trial data were harmonized in four months and the submission timeline moved up by 60 days.

Last updated · ApTask Editorial Team

60 daysSubmission timeline accelerated

Clinical · Pharma · MedTech · Health IT

Challenge

What was the challenge?

A top-10 pharmaceutical company was running a Phase III oncology trial across 12 countries. Fragmented SAS reporting standards across sites were threatening their planned FDA submission window — every harmonization cycle was adding two weeks of rework.

Solution

What did ApTask deliver?

ApTask stood up a follow-the-sun delivery team of SAS programmers and clinical data managers operating out of our North America and India hubs, giving the client 18-hour daily coverage. The team built a unified ADaM dataset specification and migrated 24 months of trial data through it under a fixed SOW.

Result

What was the result?

Two years of historical trial data harmonized in four months. The client accelerated their regulatory submission timeline by 60 days and avoided what their biostatistics lead estimated would have been an additional 4M USD of internal rework.

Engagement model

Which engagement model did the clinical data program use?

A fixed Statement of Work under Managed Solutions. The healthcare practice states the fit directly: clinical placements and health-IT direct hires run through Strategic Workforce Staffing, while clinical trial programs and EHR-implementation projects fit Managed Solutions (SOW) — fixed scope, milestone-based acceptance, ApTask’s risk on substitution. Global clinical research talent payrolls through the Employer of Record practice.

At a glance

What are the facts of this engagement, and where are they stated?

Every engagement-specific row below restates a sentence from the Challenge, Solution or Result sections above, which are the case study as ApTask publishes it; the vertical row cites the case-studies hub and the service-page row the page that states the engagement model’s terms. No figure appears here that is not stated there, and the client stays anonymised exactly as the source anonymises it.

Global clinical trial data harmonization for an oncology pipeline: the engagement at a glance, with the section or page that states each fact
ItemDetailStated in
ClientA top-10 pharmaceutical company running a Phase III oncology trial across 12 countriesChallenge, above
VerticalHealthcare & Life Sciences — clinical, pharma, MedTech, health ITCase studies hub
TeamFollow-the-sun SAS programmers and clinical data managers across the North America and India hubs, 18-hour daily coverageSolution, above
Engagement modelA fixed Statement of WorkSolution, above
Service pageManaged Solutions (SOW) — the model the healthcare practice names for clinical trial programs: fixed scope, milestone-based acceptanceHealthcare staffing
TimelineTwo years of historical trial data harmonized in four monthsResult, above
OutcomesRegulatory submission timeline accelerated by 60 days; an estimated additional 4M USD of internal rework avoidedResult, above

Healthcare & Life Sciences

Why does ApTask staff healthcare & life sciences this way?

Where clinical expertise meets technical execution. Our healthcare team places SAS programmers, medical-device engineers, pharma quality leads, and Epic / Cerner implementation consultants — often on the same program. Every clinical candidate is credential-verified before we present them: licenses, board certifications, and role-relevant training checked against source-of-truth registries.

How it works

How does a Statement of Work engagement run at ApTask?

Five steps, as the Managed Solutions page describes them: a paid two-week discovery sprint that produces the SOW itself, a named team drawn from the authenticated network, work shipped in 2–4 week milestones with hard acceptance criteria, transparent operations on the team’s own board, and final acceptance with knowledge transfer. Payment ties to milestone acceptance, not to time-and-materials drift.

  1. 01

    Paid discovery sprint

    A two-week scoping engagement that produces the SOW itself: deliverables, milestones, acceptance criteria, communication cadence, and escalation paths. If you don’t proceed after discovery, the SOW is yours to take elsewhere.

  2. 02

    Named team composition

    The delivery team is drawn from our authenticated network: technical lead, contributors, QA, project manager, and executive sponsor. You see the named roster and hours before signing.

  3. 03

    Milestone cadence

    Work ships in 2–4 week milestones with hard acceptance criteria. Payment ties to milestone acceptance, not to time-and-materials drift, so you can pause, accelerate, or descope at any boundary.

  4. 04

    Transparent operations

    You get the team’s Jira or Linear board, the same standups your internal teams run, and a weekly executive dashboard — nothing offshored to a black box, everything auditable in real time.

  5. 05

    Acceptance & knowledge transfer

    Final acceptance against the SOW criteria, a structured knowledge-transfer to your internal team, and a post-engagement support window. We optimize for a clean handoff, not the next renewal.

Healthcare & Life Sciences case study, the questions we hear most.

Who was the client in the oncology data harmonization case study?

A top-10 pharmaceutical company running a Phase III oncology trial across 12 countries. ApTask does not name case-study clients on the site; reference customers are available under NDA, and the full attribution can be shared during the strategist call.

How was the follow-the-sun clinical data team structured?

SAS programmers and clinical data managers operating out of ApTask’s North America and India hubs, giving the client 18-hour daily coverage. The team built a unified ADaM dataset specification and migrated 24 months of trial data through it under a fixed SOW.

What did the 60-day acceleration save the client?

The client avoided what its biostatistics lead estimated would have been an additional 4M USD of internal rework, on top of accelerating the regulatory submission timeline by 60 days. Two years of historical trial data were harmonized in four months.

Which checks apply to clinical data talent on an engagement like this?

FDA 21 CFR Part 11 system experience for pharma IT and GxP and ICH-GCP training validation for clinical research talent are on ApTask’s healthcare screening list. Credentialing closes before submission, so nothing reaches the hiring loop before those checks are in the file.

A submission window under pressure?

Tell us the trial phase, the systems in scope and the deadline. We will scope a follow-the-sun SAS and clinical data team under a fixed SOW, with the regulatory checks closed before anyone starts.