Astrix Offers Strategic Consulting and Implementation Support for Regulatory Affairs and Clinical Operations Solutions
Astrix is distinguished by its seasoned staff, comprising professionals with scientific backgrounds and years of Regulatory and Clinical experience. We offer a breadth of services focused on aligning with your team’s goals for innovation across your organization or delivering for specific clinical study timelines.
Technology Agnostic Approach Benefits The Client
Our clinical research technology consulting brings a solution-agnostic approach that allows us to evaluate the solution marketplace without bias, ensuring the best fit for your needs. We have developed models designed to deliver value and cost savings, and we conduct refined vendor evaluations focused on use cases relevant to clinical and regulatory teams. We provide industry-leading blueprints, broken down into project phases, to drive targeted process improvements and technology implementations.
Our teams are ready to provide strategic consultation and comprehensive services to ensure your company meets its clinical development goals. With our expertise and dedication, we aim to support your success every step of the way.
Clinical Trial
Consulting Services
- CTMS selection and implementation
- Strategic Consulting & Planning for Clinical & Regulatory Systems
- Process & System Assessments and Roadmaps
- Business Process Optimization
- System Implementation, Optimization, and Validation
- Change Management
- Computer Systems Validation
Astrix Consulting Services is capable of supporting the entire Clinical and Regulatory lifecycle. Our broad set of solutions are delivered with practical technical and industry expertise.
Some of our core services include the following
Data
Readiness
- Workflow and Data Orchestration Platforms
- Data Governance Programs
- Reference and Master Data, Data Stewardship, Data Catalogs, Critical Data Structure Harmonization
- Improved Data Management Technologies
- Flexible Data Modes, Universal Data Standards, Data as a Product: Data Fabrics and Meshes, etc.
AI &
Machine Learning
- Automated Content Generation
- Case Report Forms, Narratives, Informed Consent Forms, Summary of Clinical Efficacy, etc.
- Regulatory Insights & Analytics
- Health Authority Questions, Regulatory Requirements, etc.
- Study Design &Trial Mgmt.
- Learnings from previous study designs, patient recruitment strategies, etc.
Implementation &
Change Management
- Business Analysis
- Business Process Optimization, User Personas, Stories & Requirements, etc.
- Testing & Validation
- UAT & Test Scripts, Testing Support, Validation Documentation, etc.
- Program and Project Management
- Program/workstream Oversight & Planning, Risk Management, Vendor Management, etc.
- Organizational Change Management
- Impact Assessment, Communications Planning, SOP/Training Development, etc.
LET´S GET STARTED
Contact us today and let’s begin working on a solution for your most complex strategy, technology and staffing challenges.
CONTACT USSample Customer List
Astrix has worked with the leading companies in the pharmaceutical and biotech industries. Over the last 25+ years we have cultivated a reputation as having the highest quality resources and industry expertise. A small sample of some of our clients with whom we delivered Clinical Research Technology Projects are listed below.
We have successfully completed a wide array of project types for our clients that includes the following project categories
Regulatory Projects
- Registrations Tracking
- Submissions Management
- Authoring
- Publishing
- Archive
- IDMP Readiness
Clinical Research Technology Projects
- Study Design
- Study & Site Startup
- Study Management
- Patient Data Collection & Management
- Sample Management & Biobanking
- Clinical Results Analysis
- GXP Compliant Implementation
Our Clinical & Regulatory Resources
Selection of Clinical Research-focused blogs
AI in Drug Repurposing: Finding New Uses for Existing Medications
The field of medicine has seen an explosion of technological advancements in
Clinical Trials: Trends to Watch For In Next 5 Years
Clinical trials are at the heart of medical innovation, driving the development
The Benefits of Implementing Digitized SoA in Clinical Research Protocols
The Schedule of Assessments (SoA) in clinical research protocols serves as one
Clinical Research Software Partners
Astrix partners with some of the leading technology companies in the clinical research and R&D space. While remaining completely vendor agnostic, we develop world class skills with our team of technology consultants so we can deliver the best solutions in the right context to our clients