Primary Service Lines
At Nerrele we cover a wide gamut of technical, clinical and regulatory related projects with a focus on serving the pharma, medical research, medical device and patient health industries.
Looking to partner with us? Nerrele supports federal contractors and can fulfill small business set aside (SBSA) requirements for a number of federal programs. Contact us to find out how.
The following is a subset of services we specialize in:
Data Management Services
Clinical coding
Clinical data monitoring
Crucial Data Solutions products and support
Medidata Rave, and Oracle Clinical support
Data warehousing and AI driven analytics
SDCC (Statistical Data Coordinating Centers)
Biostatistics
Database builds and quality checks
OQ/PQ, UAT and database validations
Information Technology Services
21 CFR Pt 11 support and guidance
CMMC (Cybersecurity Maturity Model Certification) compliance support
NIST 800-171, 53 support and guidance
SOP and P&P drafting
FOCI (Foreign Ownership, Control or Influence) guidance
FedRAMP guidance
HIPAA support
IT Securities planning
IT DR and BCP (Disaster Recovery and Business Continuity) planning
Infrastructure engineering, planning and migrations
Security reviews and audits
Quality Assurance / Quality Management Services
GcP/GxP reviews and audits
Clinical coding training and certifications
SOP and P&P auditing
Process management auditing
Kaizen and Six Sigma consulting
HIPAA audits
Lean Manufacturing guidance (Medical Device, Pharma)
Industry Partners
Founded in 2010, Crucial Data Solutions (CDS) provides the most innovative and affordable data collection and clinical trial management technology on the market today. TrialKit, our cloud-based platform available via a web interface and downloadable native mobile app, enables end-to-end clinical trial management for pharmaceutical, biotechnology, and medical device companies of all sizes. Design and deploy regulatory compliant studies in days instead of weeks using our intuitive forms designer that requires no programming. Over 10,000 global users have leveraged the flexibility of TrialKit to deploy over 1,100 studies across all phases of drug and device development.