Oncology
Dose-escalation Phase I through registration-directed Phase III, with RECIST-based response, OS/PFS survival analysis, and biomarker-stratified subgroups.
Where to start
Twelve therapeutic areas, one accountable team
Pick the area that matches your program to see how we scope endpoints, data flow, and site coordination — or talk to us if your protocol spans more than one.
Neurology & CNS
Rater-administered scales, placebo response management, and biomarker/imaging integration across dementia, Parkinson's, MS, and psychiatric indications.
Allergy & Respiratory
Spirometry and pulmonary function data, exacerbation endpoints, and allergen challenge study support across asthma, COPD, and allergic rhinitis.
Cardiovascular
Event adjudication, ECG/Holter data management, and long-term outcomes follow-up for hypertension, heart failure, and post-MI/ACS populations.
Endocrinology & Metabolic Disease
HbA1c, CGM, and wearable device integration for diabetes, obesity, and thyroid disorder programs with long treatment and follow-up periods.
Anti-Infective & Vaccines
Microbiological eradication endpoints, viral load and susceptibility data, and vaccine immunogenicity support for antimicrobial and prophylactic programs.
Rare Disease
Natural history and registry studies, small-N adaptive designs, and novel or surrogate endpoint strategy for ultra-rare, dispersed populations.
Immunology
Composite disease-activity indices, immunogenicity sampling, and biosimilar comparability designs across rheumatoid arthritis, psoriasis, and lupus.
Dermatology
PASI/EASI and investigator scoring, photographic documentation, and patient-reported outcomes across topical and systemic study designs.
Gastroenterology
Endoscopic and histologic central reading, IBD activity indices, and NASH/MASH biopsy endpoints across inflammatory and metabolic liver disease.
Medical Devices
IDE and pivotal device trials, MDR/IVDR post-market clinical follow-up, and device-specific technical success and malfunction endpoints.
Ophthalmology
BCVA and OCT central reading, intraocular pressure data, and long-term retinal safety follow-up across AMD, DR/DME, and glaucoma programs.
What doesn't change
Whatever the indication, the same standard applies
The endpoints, imaging, and data sources shift by therapeutic area. The team, the data quality, and the accountability don't.
One accountable team
Biostatistics and Clinical Operations work from the same protocol and timeline regardless of indication, so nothing drifts between handoffs.
Endpoint-literate biostatistics
Analysis plans built around the endpoints each indication actually uses — composite indices, central-read imaging, survival analysis, or PRO instruments.
The same rigor everywhere
Documented SOPs, CDISC-aligned data, and Pinnacle 21 validation apply the same whether the protocol is a Phase I dose-escalation study or a Phase III outcomes trial.
What sponsors say
Feedback from across therapeutic areas
Common questions
Before you scope a study by indication
Don't see your exact indication?
Tell us your therapeutic area, phase, and key endpoints — we'll map a Biometrics and Clinical Operations model that fits the protocol.