We are passionate about data analytics; laboratory systems; data integrity; business systems and processes; and software design, development, implementation and support. Nothing is more satisfying than to see a team working as one to solve difficult analytical problems and help people become more productive and effective.
We are all experienced in quality management systems, quality system regulations, software system development, business process analysis/modeling, computer systems validation, quality system implementation/support activities, project management, and documentation development; as well as providing solutions for global regulatory requirements and corresponding SDLC activities.
Our Analytical Operations team applies a wide variety of tools and systems, including:
- Data Visualization Tools – SAS Graph Template Language (GTL), CDS Graphics
- Data Analytical Tools – SAS Macro, SQL, BASE (with certification), STAT
- Operating Environments – PC SAS, UNIX SAS
- Clinical Datasets – Electronically Captured Data, SDTM, ADaM
Additionally, our team has the following qualifications:
- Extensive industry experience with SAS and clinical data analysis and reporting (TLGs) with proven strengths in CDISC format data for both SDTM and ADaM
- Clinical trial analytical contributions to CSR (Clinical Study Reports) and NDA (New Drug Application)
- Broad expertise in various therapeutics areas in Phase I-IV (oncology, Alzheimer’s, Hyperphenylalaninemia, Phenylketonuria, Neuralgia, Ocular Inflammation, Huntington’s Disease)
- Demonstrative experience with oncology-specific statistical supports (ADaM –TTE datasets developments, Overall Survival, Objective Response Rate analysis)
Our Laboratory Operations team is led by a former analytical chemist, bringing a strong technical background in understanding FDA, ICH and other regulatory CMC requirements. This includes through all phases of pharmaceutical/biologics development, post-approval, and life-cycle of the product on a global level. This includes:
- Experience with bioanalytical characterization (small molecule/lipids/nucleic acids/proteins/polymers)
- Experience with global submissions (IND, NDA, BLA) for both small and large molecules
- Proficiency with analytical and data analysis software (Matlab, SAS, Empower, Chemstation, SAS JMP, Prism, Spotfire).
Our SDLC team is led by an experienced business process and systems development professional, bringing a rich depth of experience to each phase of the Software Development Life Cycle (SDLC). It works closely with internal Subject Matter Experts to establish effective policies and procedures related to Computerized System Validation (CSV): Part 11 Compliance and Computerized Systems Policy, Electronic Signature and Record Policy, Security Policy, Computerized System Change Control, Validation of GxP Computerized Systems, Problem Reporting, Risk Assessments, Periodic Review.
The team can perform and lead independent verification/validation, CSV projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle, including: Computer System Validation Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review.
Our team works closely with key leadership to establish Life Sciences Data Governance Models to demonstrate regulatory compliance with data integrity initiatives, including:
- Data Governance – the organization with its data
- Business Rules – common definitions and controls
- Data Quality – data and turning it into a trusted source
- Data Storage – storing, protecting and providing audit trails
- Data Movement – turning data into controlled actions through downstream systems
Our IT team is led by a trained and experienced biochemist with a PhD in Information Technologies. He is results-oriented and very focus-driven.
He leads a seasoned and dedicated team of software developers, database architects, content developers, and integration specialists for customized data solutions tailored for the life sciences. The team specializes in the following:
- Regulatory Information Management Systems
- Content Management Systems
- Configuration Management Systems
- Data and System Integration/Migration
- Data Analysis and Reporting - Dashboard Metrics Development
- Data Disaster Recovery Planning
- IT/Business Process Mapping
Please reach out to us at our team email address: Teams@Soltima.com; or call our Team Lead hotline at (650)-550-0497.