Biostatistics. Statistical programming.
CDISC services.
Data analytics & Systems.
Regulatory data standards & submissions.

At Softworld Life Sciences, our biostatisticians and statistical programmers use their data and analytic capabilities to help sponsors bring their products to market in a safe, compliant, and timely manner.

Our data scientists partner with our data management and regulatory data standards & submissions experts to deliver quality data collection, analysis, reporting, and submission solutions to the life sciences industry in the US and across the globe.

Why choose Softworld Life Sciences?

Drug development and research expertise.

Softworld Life Sciences consultants are highly experienced in the FDA approval process, and with Softworld, the consultants who sell the work are also the ones who manage the work to ensure the success of the project.

Speed.

Because Softworld Life Sciences proactively recruits within five key skill disciplines, we are able to provide technical resources faster than our competitors in these areas. Positions can typically be filled in 24 to 48 hours. We eliminate waste in the hiring process and make hiring easier and more efficient.

Flexibility.

Softworld Life Sciences provides can provide resources and solutions in the manner than best matches each client’s specific needs. This gives our clients greater control, less risk, and a better cost structure that traditional outsourcing or staffing solutions.

Softworld Life Sciences recruits talent in these key skill disciplines

Biometrics

  • Biostatistics
  • SDTM / ADaM
  • CDISC/CDASH Analyst
  • SAS Programming
  • Data Mapping

Clinical

  • Clinical Data Management
  • CDR
  • Clinical Project Management
  • EDC and Study Build
  • Medical Coding
  • Clinical Operations

Validation

  • Process
  • Cleaning
  • Aseptic
  • Equipment Packaging
  • Protocol Writing
  • CQV / FAT
  • CSV
  • Commission / Decommission
  • Metrology

GCP, GMP, GLP, GXP

  • Metrics
  • QMS
  • Best Practices
  • Audit / Mock – Prep
  • Process Improvement
  • 21 CFR Part 11

Regulatory

  • Submission Management
  • IND / NDA
  • Dossier Compilation
  • Compliance Remediation
  • Regulatory Strategy
  • Post approval maintenance

Quality

  • CAPA / Root Cause
  • 483 / Consent
  • Deviation
  • Process Improvement
  • SOP / Documentation
  • Batch / Deviation Review
  • Protocol Writing