CRO Selection Toolkit
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Free practical tools to support your MedTech clinical trial planning
Planning a clinical study strategy to support regulatory clearance, (FDA, CE, RoW or Market Access), this will be one of the most significant investments in the go-to-market business plan.
Getting the right partner isn’t just important, it’s critical.
Whether you’re navigating this process for the first time or refining your approach, HWA has developed a few practical tools to help you make confident, informed decisions.
Why we built this
We’ve been on both sides of the clinical trial journey, leading internal study strategy to achieve regulatory clearance and working within CROs delivering execution. We have made mistakes and learned what matters most.
We’re not in the CRO business. But we do know that selecting the right partner early can save both time and cost, while also dramatically improving your chances of getting it right the first time.
These tools were created through this lens.
What’s Included
· CRO RFP Template – Ask the right questions, not just the usual ones
· CRO Scoring Sheet – Compare partners objectively by what matters to you
· Sample Tools & Guidance – Timelines, communication models, and budget considerations
· Introductions – Want a second opinion or connection to a vetted CRO, We are happy to help.
To schedule a free consult on Clinical Study planning
Is it just semantics? Not quite.
The terms "clinical study" and "clinical trial" are often used interchangeably, but there is a subtle distinction, especially in regulatory or academic contexts
A clinical study is the umbrella term for any research involving human participants to better understand health, disease, or the effects of medical products.
Two main types of clinical studies:
· Clinical Trials (interventional)
· Observational Studies (non-interventional)
A clinical trial, more specifically, is a type of clinical study in which participants receive specific interventions and outcomes are actively measured, (e.g., device, drug, procedure). These are most often for global regulatory submission and specifically in the U.S. to define Market Access (i.e., coding and reimbursement).
Key characteristics:
· Interventional (researchers assign a treatment)
· Designed to evaluate safety, effectiveness, or performance
· Often used for regulatory approval (e.g., FDA, CE mark)
So, All clinical trials are clinical studies, but not all clinical studies are clinical trials.
