Prosoft Software, Inc. dba Prosoft Clinical
Prosoft Clinical is a full-service Clinical Research Organization established in 1995, specializing in pharmaceutical, biotech, and medical device industries. They support clients from early product concept through post-marketing studies, offering a wide range of services including clinical operations, data management, biostatistics, medical writing, regulatory operations, and product development. Their internal systems and experienced professionals ensure efficiency, cost-effectiveness, and high-quality support for product development and regulatory submissions.
Industries
Nr. of Employees
small (1-50)
Prosoft Software, Inc. dba Prosoft Clinical
Wayne, Pennsylvania, United States, North America
Products
Web-based electronic data capture platform
A browser-based EDC platform providing real-time reports and metrics, programmed edit checks, auto-coding, integration with randomization and data review systems, and security controls consistent with 21 CFR Part 11.
Interactive randomization and IVRS system
A randomized allocation and interactive voice/web response system integrated with data capture to support randomization and investigational product distribution.
Adaptive study design platform using predictive modeling
A platform that monitors trial progress in real time and uses predictive modeling to project outcomes and support adaptive design decisions.
Web-based electronic data capture platform
A browser-based EDC platform providing real-time reports and metrics, programmed edit checks, auto-coding, integration with randomization and data review systems, and security controls consistent with 21 CFR Part 11.
Interactive randomization and IVRS system
A randomized allocation and interactive voice/web response system integrated with data capture to support randomization and investigational product distribution.
Adaptive study design platform using predictive modeling
A platform that monitors trial progress in real time and uses predictive modeling to project outcomes and support adaptive design decisions.
Services
Clinical trial management
Study management services including site monitoring, contract negotiation, drug supply coordination, timeline development, and study close-out reporting.
Data management and EDC/IWRS services
Design and operation of EDC and IWRS systems, CRF annotation, database build, edit-check programming, data validation and coding per WHO Drug and MedDRA.
Biostatistics and statistical programming
Protocol development, sample size calculations, statistical analysis planning, programming of analysis tables and support for data safety committees.
Regulatory operations and submissions
Compilation of regulatory submission sections, coordination of NDA/ANDA/510(k)/PMA materials and electronic submission via ESG or eCTD vendors.
Medical and regulatory writing
Preparation of protocols, SOPs, clinical development plans, investigator brochures, submission-ready clinical study reports, publications and meeting posters.
Consultative and strategic services
Due diligence, program design, regulatory meeting preparation, advisory board support and lifecycle management consulting.
Clinical trial management
Study management services including site monitoring, contract negotiation, drug supply coordination, timeline development, and study close-out reporting.
Data management and EDC/IWRS services
Design and operation of EDC and IWRS systems, CRF annotation, database build, edit-check programming, data validation and coding per WHO Drug and MedDRA.
Biostatistics and statistical programming
Protocol development, sample size calculations, statistical analysis planning, programming of analysis tables and support for data safety committees.
Regulatory operations and submissions
Compilation of regulatory submission sections, coordination of NDA/ANDA/510(k)/PMA materials and electronic submission via ESG or eCTD vendors.
Medical and regulatory writing
Preparation of protocols, SOPs, clinical development plans, investigator brochures, submission-ready clinical study reports, publications and meeting posters.
Consultative and strategic services
Due diligence, program design, regulatory meeting preparation, advisory board support and lifecycle management consulting.
Expertise Areas
- Clinical trial management
- Biostatistics and statistical programming
- Data management and CDISC implementation
- Adaptive trial design and predictive modeling
Key Technologies
- Electronic Data Capture (EDC)
- Interactive Web Randomization System (IWRS) / IVRS
- Adaptive design using machine learning and predictive modeling
- CDISC standards (SDTM, ADaM, SEND, Define-XML)