Portfolio management & asset valuation
Capitalize on your portfolio’s full potential with optimization strategies that consider every aspect of drug development. Our efforts, supported by integrated expertise in clinical, regulatory, and market access strategy and planning, help you make earlier, faster, more informed decisions about risk and reward, so each asset has its greatest chance for success.
Early development and innovation
Navigate the complexity of early-stage development with our integrated approaches and novel ideas. Through a unified strategy that addresses every aspect of development, we enable faster decision making while establishing a sound foundation for later-stage work — guiding you in biomarker selection, healthy volunteer or patient recruitment, safety, supplies/logistics, regulatory strategy, and more.
SERVICES
- Phase I clinical trials
- Proof of concept: Phase Ib-IIa
- Patient engagement strategy and enrollment solutions
- Site Alliance Network and KOL engagement
- Protocol optimization
- Regulatory strategy
- Market access strategy and delivery
- Biomarker and genomic medicine strategy
- Clinical trial supply and logistics
- Patient inclusion
- Medical communications
- Real world evidence
- Integrated evidence generation planning
Integrated clinical development
Harness the power of our whole-study solutions, designed to ensure patient safety, data integrity, regulatory compliance, and scientific rigor. Our integrated strategies address these priorities and more. They allow us to reduce burdens, mitigate risk, and operate efficiently within timelines and budget, while keeping the patient’s needs at the center of everything.
SERVICES
- Phase IIb-IV clinical trials
- Real world evidence
- Patient engagement strategy and enrollment solutions
- Protocol-driven, customized site solution strategy
- Regulatory approval, compliance, and outsourcing
- Market access strategy and delivery
- Clinical development technology optimization
- Clinical trial supply and logistics
- Patient inclusion
- Medical communications
- Drug safety and pharmacovigilance
- Integrated evidence generation planning
Approval and access
Connect with our team of former regulators and HTA professionals, who helped shape the current landscape. We put our earned experience to work for you as we guide global regulatory submissions, compliance activities, market access strategy, launch planning, and more, with advice tailored by our localized knowledge and diverse therapeutic prowess.
Value substantiation lifecycle management
Expand your value story and amplify your product’s impact with value substantiation and lifecycle management. Our integrated team uses the power of real-world evidence (RWE), regulatory insights, and therapeutically aligned medical writing to bolster your value story. By delivering data that satisfies payers and regulators, we build trust with patients and their healthcare providers.
