- Software and IT infrastructure consulting
- Digital transformation and cloud consulting (including HIPAA-compliant cloud selection)
- UI/UX design services
- QA consulting
IT Services and Solutions for Contract Research Organizations (CROs)
In healthcare IT since 2005, ScienceSoft engineers, supports, and modernizes clinical trial software for CROs. Our proficiency in meeting GCP, FDA, HIPAA, GDPR, and Cures Act requirements ensures regulatory compliance. With ISO 13485, ISO 9001, and ISO 27001 certifications, we deliver efficient solutions that enhance trial timelines, enable real-time monitoring of trial progress, and maintain data integrity across multiple sites.
Software Solutions for Contract Research Organizations (CROs)
Clinical trial management systems (CTMS)
Clinical data management systems (CDMS)
Electronic trial master file (eTMF) software
Electronic clinical outcome assessment (eCOA) solutions
Electronic data capture (EDC) systems
Randomization and trial supply management (RTMS) systems
Regulatory information management systems
Clinical trial portals
Supply chain management portals
Analytics solutions for contract research organizations
Financial management software
eConsent software
Services for Contract Research Organizations (CROs)
IT consulting
Software engineering
Modernization and integration
- Application modernization
- Cloud migration
- Software integration (e.g., integrating CTMS with LIMS and EHR via FHIR APIs, USCDI datasets, or CCDA documents)
Cybersecurity
- Cybersecurity consulting
- Security audit
- Penetration testing for healthcare
- Managed security services
- Security implementation services, including SIEM implementation
- Upgrading information security and compliance safeguards
Compliance
- Compliance consulting (e.g., on GCP, FDA, HIPAA, GDPR, and 21st Century Cures Act requirements)
- Compliance assessment (e.g., for FDA 21 CFR Part 11, ICH E6(R2), HIPAA, or 21st Century Cures Act interoperability requirements)
- Ongoing compliance management for clinical trial software
Data management and analytics
- Healthcare data warehousing
- Healthcare data management (with support for standard terminologies such as LOINC, SNOMED CT, and RxNorm, as well as ICD-10 and CPT codes for structured trial data)
- Business intelligence
IT support
- L1, L2, L3 help desk
- Monitoring and troubleshooting of clinical trial software
- IT infrastructure management
- Digital workplace management