Email:
global@GCP-ClinPlus.com
Clinical data management services designed to ensure the integrity, accuracy, and compliance of your trial data from protocol design through database lock.
Our biostatistics services form the foundation of successful clinical trials, ensuring methodological rigor, regulatory compliance, and robust evidence generation for your drug and medical device development programs.
Expert SAS programming services to help sponsors convert complex clinical data into submission-ready datasets, tables, listings, and figures.
Comprehensive PK/PD data analysis to support dose selection, optimize study design, and accelerate regulatory decision-making.
professionals and leadership with experience from top pharma companies (e.g., Novartis, AstraZeneca).
platforms, patented tools, and certified in 10+ major EDC systems.
completed projects and support for over 160 product launches.
across oncology, gene therapy, rare diseases, and more.
FDA interaction and CDISC Gold Member with 12+ years of global submission experience.
FSP, hybrid, and strategic consulting options.
repeat business and quarterly satisfaction tracking.
US leadership team with 30+ years of industry experience, including veterans from Novartis, Celgene, AstraZeneca, and other leading pharmaceutical companies.
Core team averaging 17+ years of experience in biometrics and clinical research.
31%+ employees with 5+ years of experience:
2/3 internally trained
1/3 from multinational companies → Ensuring stability & growth
30+ expert teams built over 7 years, maintaining industry-leading expertise.
Therapeutic expertise spanning oncology, gene therapy, hematology, ophthalmology, rare disease, metabolism, and many other areas.
20 years of close collaboration with top statistical experts from five leading universities.
Former FDA statistical review experts providing guidance and support.
CDISC Gold Member with 12 years of experience in CDISC submissions to FDA, EMA, and PMDA.
Active participant in CDISC guideline creation.
GCP ClinPlus delivers exceptional expertise with genuine commitment to our projects. Their team demonstrates remarkable responsibility at every stage, consistently going above and beyond. In an industry where dedication matters, they've proven themselves an invaluable partner for our success.
After enrollment challenges with our previous CRO threatened our study timeline, GCP ClinPlus stepped in and transformed our project. Their team rapidly accelerated patient recruitment beyond our expectations and put our critical study back on track. Their clinical expertise and swift implementation proved decisive in securing our study's success.
GCP ClinPlus stands out for their exceptional responsiveness and customer focus. Their team consistently prioritizes our needs with prompt, thoughtful solutions to every challenge. Their combination of technical excellence and client-centered approach makes them a truly strategic partner in our development programs.
