Phase I – III
Forward-looking science from Phase I to III.
+500
Professionals
5
Therapeutic areas
+40
Countries
Built for your exact clinical scenario
You have a Phase I asset, but lack an internal operations team.
We act as your extended clinical department. You gain senior regulatory guidance and flexible trial designs from day one, avoiding the overhead of building an in-house team.
You are running a Phase II proof-of-concept that demands deep therapeutic expertise.
We align our operational agility with deep medical knowledge in your specific indication. Our direct governance model ensures fast decisions and robust data integrity to validate your asset.
You are scaling to a multi-region Phase III trial and need global execution.
We activate high-performing sites across 40 countries to meet rigorous recruitment targets. You secure global reach while keeping your trial a top priority, backed by dedicated teams that stay.
Advancing your clinical development from Phase I to III
Early Phase I–II
Guided by senior medical and regulatory advisors, we build customized strategies to navigate early clinical development with absolute operational efficiency.
- First-in-human and proof-of-concept studies
- Micro-dosing: single and multiple ascending dose (SAD/MAD)
- Drug-drug and food-drug interactions
- Flexible trial design (e.g., adaptive, basket/umbrella)
- Biosimilarity and bioequivalence
- Regulatory strategy and submission (CTA/ITA, PIP, IND, PMA/510k)
- Pharmacokinetics/Pharmacodynamics (PK/PD)
- PET imaging
- Bioanalytical support
- Pediatric populations
- Elderly populations
- Rare disease and orphan indications
- Medical devices
- Direct executive oversight through our TFS governance model
Phase II/III
We provide comprehensive operational capabilities for pivotal studies. You receive the same level of scientific dedication and attention to detail, regardless of your asset size or therapeutic area.
- Dedicated project manager assigned in agreement with your team
- Continuous and transparent communication throughout the trial
- Comprehensive project kickoff and planning with built-in flexibility for protocol changes
- Accelerated study start-up through our trusted investigator site network
- Robust EDC, CTMS, and clinical analytics integration to ensure data integrity
- Real-time metrics review via our customer portal
Securing the path for sponsors’ science.
How modern technology is redefining Phase I–III trial
Global presence designed for local agility
International scale, deep local roots
We have built our structure by integrating established clinical teams across key markets, rather than handing off trials to unknown third parties. Operating directly on the ground allows us to navigate local regulations, streamline ethics approvals and keep recruitment on track.
