IKCON PHARMA
IKCON PHARMA is a contract research organization (CRO) dedicated to providing innovative services, solutions, and staff augmentation to the pharmaceutical, biotechnology, and medical devices industries. The company supports clinical trials and product development activities by leveraging technology and domain expertise, aiming to improve patient lives globally. With a focus on digital transformation, they aim to support clients in developing novel medicines, streamlining clinical development, and ensuring high standards of quality, compliance, and safety.
Industries
Nr. of Employees
small (1-50)
IKCON PHARMA
51 Cragwood Rd, Suite#302, South Plainfield, New Jersey 07080
Services
End-to-end CDM from CRF design through database lock, including data validation, query management, medical coding, interim reviews, database locking and archival, and eTMF integration.
Statistical study design and analysis including adaptive designs, SAP development, sample size calculations, trial simulations, interim/final analyses and integrated safety/efficacy analyses.
Creation and QC of analysis datasets, TLFs, CDISC SDTM/ADaM implementation, Define.xml, and submission-ready datasets and programs.
Case processing, medical review, coding, narrative writing, SAE reconciliation, signal management, individual and aggregate report preparation, and annual safety reporting.
Validation planning and execution including GxP/21 CFR Part 11 assessments, validation master plans, SRS/SDS/SCS documentation, IQ/OQ/PQ, requirements traceability, and validation summary reporting.
Staffing and technical services to implement electronic data capture systems, including configuration, integration, UAT, and report/metric development to support trial automation and data capture.
End-to-end CDM from CRF design through database lock, including data validation, query management, medical coding, interim reviews, database locking and archival, and eTMF integration.
Statistical study design and analysis including adaptive designs, SAP development, sample size calculations, trial simulations, interim/final analyses and integrated safety/efficacy analyses.
Creation and QC of analysis datasets, TLFs, CDISC SDTM/ADaM implementation, Define.xml, and submission-ready datasets and programs.
Case processing, medical review, coding, narrative writing, SAE reconciliation, signal management, individual and aggregate report preparation, and annual safety reporting.
Validation planning and execution including GxP/21 CFR Part 11 assessments, validation master plans, SRS/SDS/SCS documentation, IQ/OQ/PQ, requirements traceability, and validation summary reporting.
Staffing and technical services to implement electronic data capture systems, including configuration, integration, UAT, and report/metric development to support trial automation and data capture.
Expertise Areas
- Clinical data management
- Biostatistics and study design
- Statistical programming and CDISC implementation
- Pharmacovigilance and drug safety
Key Technologies
- Electronic data capture (EDC) platforms
- Interactive response technology (IRT)
- Clinical trial management systems (CTMS)
- Electronic Trial Master File (eTMF) systems
News & Updates
IKCON PHARMA partners with Bioclinica to support clinical trial project scaling and streamlining.
Partnership to support clinical protocols with Bioclinica’s platform, including IRT and EDC.
IKCON PHARMA partners with Bioclinica to support clinical trial project scaling and streamlining.
Partnership to support clinical protocols with Bioclinica’s platform, including IRT and EDC.