18
specialists onboarded in under 3 weeks
$0
entity setup cost across 3 countries
60–70%
lower cost vs. equivalent US hires
100%
audit-ready documentation from day one
Client Details
Company
Confidential
Headquarters
United States
Service Duration
6.2 years - Ongoing
Industry
Life Sciences - Contract Research Organization (CRO)
Service
Employer of Record (EOR) — Clinical Data Managers & Pharmacovigilance Specialists
Engagement
New trial support, multi-country build-out
What Do They Do?
Our client is a global CRO providing clinical data management, pharmacovigilance, and trial support services to pharmaceutical sponsors. Landing a new trial meant standing up clinical data and drug-safety coverage across three markets at once – India, Eastern Europe, and Latin America – inside a 30-day window tied to the sponsor’s trial start date.
The Challenge
Pharmacovigilance outsourcing is structural demand, not a cyclical spike — India in particular has become what industry analysts now describe as the global back-office for drug safety, and mid-level PV talent with 3–6 years of experience is simultaneously the most in-demand and most mobile segment of the market. The CRO’s timeline collided directly with that reality:
- Opening entities in India, Eastern Europe, and Latin America to hire compliantly would have taken 3–6 months per country and cost $50,000-plus each before a single specialist was on payroll
- The sponsor’s trial start date did not move – coverage needed to be live within 30 days across all three markets simultaneously, not staggered market by market
- Regulatory fragmentation across the three jurisdictions meant contracts, statutory benefits, and termination frameworks all needed to be handled differently – with zero room for a compliance misstep on a trial-facing team
- Every hire needed IP and confidentiality clauses enforceable under local law, given direct access to trial data and adverse-event reporting
- A 9.5-hour gap between US business hours and the time zones where customer incidents were most likely to spike overnight
- On-call engineers regularly paged at 2–4am, with visible attrition risk building in the SRE team
- Mean time to resolution (MTTR) on overnight incidents ran far longer than daytime incidents simply because fewer people were awake to respond
- Leadership wanted a dedicated India shift to close the gap, but had no appetite for opening an entity or managing a second HR system for a small offshore team
“We had a trial start date and three countries to staff before it. Entity setup was never going to fit inside that window, and cutting corners on compliance for a PV team wasn’t an option.”
— VP Clinical Operations, Global CRO
How Husys Resolved The Challenge
Husys activated EOR employment across all three countries in parallel, under a single consolidated payroll and compliance framework.
- Locally compliant contracts, with IP and confidentiality clauses built in, were issued for Clinical Data Managers and Pharmacovigilance Case Processors in each of the three markets
- Onboarding, payroll, and statutory compliance were run through one consolidated framework rather than three separate country processes, giving the CRO’s operations team a single point of visibility
- Bypassed local entity setup entirely, saving $150k+ in upfront operational costs and cutting launch timelines by 3–6 months across all three regions.
- Documentation was structured to be audit-ready from the first day of employment, anticipating the regulatory review the trial data would eventually face
The Results
The trial-support team was fully staffed and compliant inside the sponsor’s original timeline, with no market left waiting on the others.
- 18 specialists onboarded across the three countries in under 3 weeks
- Zero entity footprint required: Enabled full legal employment and tax compliance in all 3 markets without local corporate registration.
- 60–70% lower fully loaded cost versus hiring the equivalent roles in the US, consistent with current market rates for CDM and PV talent in these regions
- 100% audit-ready employment and compliance documentation in place from day one
- The CRO has since used the same standardized EOR model as its default framework for standing up trial-support teams in new markets.
“Our on-call rotation was quietly costing us senior SREs. We needed a real team in India, not another rotation band-aid.”
How Husys Can Help Your Organization?
Husys builds clinical data and pharmacovigilance teams for CROs and sponsors across multiple countries under one compliance framework, not three separate vendor relationships. If a trial start date is fixed and your data or safety coverage isn’t yet staffed in the markets you need, we can get compliant contracts in front of specialists in days, not months.
reach@husys.com
