Services
What the study should cost, who should run it, and how it should be designed.
We advise pharmaceutical sponsors on all three, from the sponsor’s side of the table. Every engagement ends in something written you can act on.
01
Study Budgeting & Quote Review
We review CRO quotes against realistic market pricing, so you know whether you are being quoted fairly and where there is room to negotiate.
This rests on more than 30 years of quoting and pricing bioequivalence, bioavailability, and bioanalysis studies for sponsors worldwide — from the side of the table that issued the quotes. We also help you build a defensible budget before you approach a single CRO.
What’s included
- Independent review of CRO quotes against market pricing
- Per-task cost benchmarks and typical ranges across study phases
- Identification of the line items most often inflated or negotiable
- Budget construction before CRO outreach begins
- Support through the negotiation itself
Deliverable: a market-benchmarked study budget and an independent quote review.
02
CRO & Site Selection
Choosing a CRO is harder to reverse than it looks. We run due diligence on the candidates, then stay on through the study.
Candidates are assessed against your protocol rather than against a generic checklist, and sourced from three decades of direct working relationships across the region.
What’s included
- Due diligence on candidate bioequivalence and bioanalysis CROs and clinical sites
- Comparative scorecard against your protocol’s actual requirements
- Milestone oversight through study conduct
- Continuous quality and compliance monitoring
- Risk assessment with written mitigation strategies
Deliverable: a comparative CRO and site scorecard with a risk-rated recommendation.
03
Study Design & Regulatory Strategy
A study that is designed around the submission is cheaper than one corrected after it.
We advise on study design, protocol strategy, and the regulatory pathway — grounded in more than 3,000 studies submitted to the EMA, US FDA, and WHO, and in what those reviewers actually accept.
What’s included
- Bioequivalence, bioavailability, and pharmacokinetic study design
- Protocol strategy and review
- Regulatory pathway for EMA, US FDA, and WHO submissions
- Biowaiver and dissolution strategy
- Guidance on local and international compliance requirements
Deliverable: a study design and regulatory strategy memo for your target markets.
Ways to work with us
The three services above are what we solve. These are the arrangements they come in.
- Independent quote review — a one-off engagement against a specific CRO quote.
- Project oversight — retained through study conduct, with milestone and compliance monitoring.
- Advisory board membership — strategic input on clinical research programs.
- Workshops and seminars — on regulatory compliance, risk management, and best practice, drawing on experience organizing international scientific conferences since 2013.
- Thought leadership content — articles, whitepapers, and technical writing on industry practice.
Not sure which of the three you need?
Most sponsors arrive with one question and leave with a clearer view of all three. Tell us what you are working on.