CRC Pharma
Clinical research and reporting organization based in New Jersey providing operational and consulting services for translational clinical development. Core strengths include biostatistics, statistical programming, clinical data management, regulatory and medical writing, pharmacokinetics/pharmacodynamics analysis, pharmacovigilance, and clinical trial transparency and anonymization services. Offers training and strategic consultancy for early-stage clinical programs and regulatory submissions.
Industries
Nr. of Employees
small (1-50)
CRC Pharma
Parsippany, New Jersey, United States, North America
Products
Clinical and regulatory support
Comprehensive clinical and regulatory support services.
Clinical / statistical programming services
Statistical programming, summary and statistical reports for non-clinical and clinical studies including CDISC standards conversion.
Biostatistics services
Biostatistics and statistical programming solutions spanning across the translational spectrum ranging from preclinical to early and late phase clinical development.
Advice on plan, design and execution of nutraceutical products
Consulting on the planning, design, and execution of nutraceutical product development.
Clinical PK and PK/PD data analysis
Clinical pharmacokinetic and pharmacodynamic data analysis services.
Expert advice on CDISC data review and compliance to US-FDA
Consulting on CDISC data standards review and US-FDA compliance.
Clinical and regulatory support
Comprehensive clinical and regulatory support services.
Clinical / statistical programming services
Statistical programming, summary and statistical reports for non-clinical and clinical studies including CDISC standards conversion.
Biostatistics services
Biostatistics and statistical programming solutions spanning across the translational spectrum ranging from preclinical to early and late phase clinical development.
Advice on plan, design and execution of nutraceutical products
Consulting on the planning, design, and execution of nutraceutical product development.
Clinical PK and PK/PD data analysis
Clinical pharmacokinetic and pharmacodynamic data analysis services.
Expert advice on CDISC data review and compliance to US-FDA
Consulting on CDISC data standards review and US-FDA compliance.
Services
Statistical planning and analysis services for nonclinical and clinical studies including SAPs, sample size, statistical reporting, and DMC support.
Generation of analysis datasets, ADaM datasets, TLFs, interim and final analyses, and CDISC dataset conversions with documentation.
On-site and off-site CDM services including CRF/eCRF design, database build, edit checks, query management, medical coding and database lock.
Anonymization of patient-level datasets, CSR redaction, and preparation/review of lay language summaries for public and regulatory disclosure.
Authorship and compilation of regulatory and scientific documents including IND/NDA/BLA/ANDA submissions, clinical study protocols, CSRs, IBs, and publication manuscripts.
Non-compartmental and population PK/PD analyses, modeling, bioequivalence and drug–drug interaction assessments to inform dosing and labeling.
Statistical planning and analysis services for nonclinical and clinical studies including SAPs, sample size, statistical reporting, and DMC support.
Generation of analysis datasets, ADaM datasets, TLFs, interim and final analyses, and CDISC dataset conversions with documentation.
On-site and off-site CDM services including CRF/eCRF design, database build, edit checks, query management, medical coding and database lock.
Anonymization of patient-level datasets, CSR redaction, and preparation/review of lay language summaries for public and regulatory disclosure.
Authorship and compilation of regulatory and scientific documents including IND/NDA/BLA/ANDA submissions, clinical study protocols, CSRs, IBs, and publication manuscripts.
Non-compartmental and population PK/PD analyses, modeling, bioequivalence and drug–drug interaction assessments to inform dosing and labeling.
Expertise Areas
- Clinical trial management and design
- Biostatistics and statistical programming
- Clinical data management and EDC
- Regulatory writing and submission support
Key Technologies
- CDISC data standards (SDTM, ADaM, SEND)
- Clinical statistical programming and TLF generation
- Clinical data anonymization and de-identification methods
- PK/PD modeling and nonlinear mixed-effects modeling
News & Updates
Two-day interactive workshop on translational research strategies, regulatory considerations and drug development held in Hyderabad, India.
Interview and discussion on regulatory drivers, anonymization methods for CDISC datasets and the role of transparency initiatives in clinical trial data sharing.
Discussion on data strategy, changing CDM landscape, data integrity and cost impacts with emerging technologies and standards.
Multiple peer-reviewed manuscripts, book chapters and conference posters spanning clinical pharmacology, PK studies, HTS, and phytopharmaceutical research (publications listed on the site).
Two-day interactive workshop on translational research strategies, regulatory considerations and drug development held in Hyderabad, India.
Interview and discussion on regulatory drivers, anonymization methods for CDISC datasets and the role of transparency initiatives in clinical trial data sharing.
Discussion on data strategy, changing CDM landscape, data integrity and cost impacts with emerging technologies and standards.
Multiple peer-reviewed manuscripts, book chapters and conference posters spanning clinical pharmacology, PK studies, HTS, and phytopharmaceutical research (publications listed on the site).