Clinical CRO and real-world evidence services
A study is a long road
Choose a team you’ll love to go the distance with.
Dual expertise in early- through late-phase clinical development and real-world evidence, delivered by hands-on clinicians, scientists, and epidemiologists with more than 25 years of experience.
We’ve done this many times
Our people know where the problems hide, because they’ve solved them before.
-
500+
Experts across
5 continents -
1,000+
Studies delivered
over 25+ years -
700k+
Participants
enrolled -
5,000+
Sites engaged
in 75+ countries
We stay for the life of your medicine
From the clinic to the real world. Our clinical development and real-world evidence teams are specialists in their own right, engaged independently or together, with one seamless handover when your program needs both.
Clinical development
Senior operational experts lead your trials, with medical monitors and biostatisticians shaping the protocol from day one.
Our clinical teams work with you on protocol design, country and site selection, and endpoints from day one, whether they run a single study or carry your program from proof of concept through approval.
- Phase I through Phase IV 100+ early phase and 250+ late-phase trials, from first dose to the trials that follow approval.
- Senior operational experts in every core role The right people on every job, from day one.
- Every study run by the people you chose The people who impressed you at the bid defense are the people who run your study.
- Tough gets us going We turn around studies others can’t. In neuroscience alone, we’ve rescued 18 studies in five years.
Real-world
evidence
Our real-world evidence practice was built by epidemiologists, not adapted from a clinical model.
Our epidemiologists quantify disease burden and treatment patterns, and work on your feasibility, endpoints, and comparators from day one, whether they join a clinical program or lead the evidence on their own.
- 400+ real-world evidence projects Real-world evidence isn’t our add-on. It’s our home turf.
- 340,000+ participants in 45+ countries Registries, database studies, and prospective cohorts, chosen to fit your question.
- On the ground where the patients are Our own teams, on the ground where disease circulates, with site networks across Africa.
- Post-approval evidence, ready before anyone asks Post-authorization safety and effectiveness studies (PASS and PAES) planned before approval, by people who have delivered them.
Choose the model that best suits your study
Full service, or just the parts you need.
Full service
Full study management, clinical or real-world. We handle everything from study design through to final report, so you can focus on your pipeline.
Why use this model?
- Complete project ownership
- Dedicated cross-functional team
- Single point of accountability
Functional service provider (FSP)
Embed our specialists within your team. Scale specific functions up or down while maintaining your oversight and processes.
Why use this model?
- Flexible resource scaling
- Seamless team integration
- Your processes, our people
Single services
Targeted expertise for specific study needs. Access individual capabilities like epidemiology, protocol design, medical writing, or biostatistics.
Why use this model?
- Specialist expertise on demand
- Quick deployment
- Deep expertise, precisely where you need it
Every phase built to earn the next
Choose the solution that fits where your medicine is now. Each one is run by specialists who have taken programs through it many times.
Early phase clinical
development
Phase I to II clinical trials
From first dose to proof of concept, designed so the result is the decision you need.
We build early phase programs around the question your next study depends on: dose, exposure, and early signal. Medical monitors and epidemiologists are involved before the protocol is fixed, and much of the work happens in patients, from Phase Ib and II proof of concept to rare and hard-to-reach populations.
- Protocol and study design We design around the decision you need to make.
- Regulatory strategy: IND, CTA, and CTIS Filed by people who know your target regions.
- Ascending-dose (SAD/MAD) trials through qualified partner units First doses in experienced hands.
- PK/PD and biomarker strategy Designed by those who know what Phase III needs.
- Adaptive and seamless Phase I/II designs Our team flexes the design, not the standards.
- Safety review and dose escalation oversight Monitors who know your medicine, deciding fast.
- Epidemiology-informed feasibility Epidemiologists who find your patients first.
- Early studies in patient populations Rare and hard-to-reach populations, run by people who know them.
Late phase clinical
development
Phase IIb to IV clinical trials
Approval is a checkpoint we meet time and again.
We build late phase programs around the things that decide them: global site management, risk-based monitoring, endpoint adjudication, and data and biostatistics teams that have carried programs through submission. That includes Phase IV commitments, outcomes trials that run for years, and studies that need a turnaround.
- Global site selection and start-up Sites we know personally, not names on a list.
- Risk-based quality management Experienced eyes on the data, watching the right risks.
- Medical monitoring and pharmacovigilance Our own specialists, on every safety call.
- Endpoint adjudication Adjudication run by those who know what holds up.
- Data management and biostatistics Statisticians who’ve taken programs through submission.
- Regulatory submission support The right people from database lock to submission.
- Rescue studies and program turnarounds Often called in late. It’s become a specialty.
- Patient recruitment and retention We keep the participants we recruit.
Real-world
evidence
Registries, safety, and effectiveness studies
Regulatory-grade evidence doesn’t stop at approval.
Disease burden, effectiveness, safety, and health economics, answered so payers and regulators can act on it. We fit the design to the question, whether that’s a registry, a database study, or a prospective cohort. More than 400 projects so far, every one supported by specialists in the field.
- Epidemiology and study design Designed for your question, not our template.
- Post-authorization safety and effectiveness (PASS and PAES) Planned before approval, by people who’ve delivered them.
- Patient registries and observational studies Teams who keep sites and participants engaged for years.
- Database and EHR analysis We choose the data source to fit the question.
- Systematic literature review Reviews that hold up, run by people who publish regularly.
- Burden of disease and health economics Health economists who speak the payer’s language.
- Vaccine effectiveness studies Our own teams, on the ground where disease circulates.
- Safety surveillance and pharmacovigilance Safety specialists watching, from one study to a whole portfolio.
Frequently asked questions
Answers to your questions about our solutions
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