Technical Solutions That Scale
We are a full-service professional services organization that provides technical writing, learning and communications, information technology (IT), and business planning services. Our team of experts has the knowledge and experience to help you achieve your goals.
Professional, Technical, & Advisory Services
Analysis
- Requirements
- Skill Gap
Training Delivery
- Classroom (in-person or virtual)
- Coaching
- Deskside
- Desktop
- Process
- Compliance
- Human Skills
Custom Learning Solutions
- Content Development (online or instructor-led)
- Video / Animation
- Technical and Medical Writing
- Communications
Learning Management
- Change Management
- Program Management
- Vendor Management
- LMS Administration
-
Analytics
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External Assets
- Engaging Presentations for All Formats
- Visually-captivating Infographics
- Interactive Communication Materials
- Videos, Webinars, Symposia
- Podcasts, Audio Enhancements
Internal Assets
- Foundational MedComms Documents (scientific platform, narrative, communications plan, etc)
- Cross-functional & Field Team Training Content
- External Presentation Training Tools
- FAQs, Annotated PDFs, SRLs
Compliance Support
- Full Referencing & Annotations
- Content Cross-check for Accuracy, Strategic Alignment, Consistency, & Compliance
- Copyright & Permission Assistance
- Pharmacovigilance Documentation
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End-to-end Process Management
- Process Creation
- Process Documentation
- Process Improvement
- Management Monitoring
Eligibility
- Vetting & Debarment
- Conflict of Interest Checks
Contracting
- Contract Creation
- Contract Execution
- FMV Verification
Payments
- Documented Work Completion
- Payment Requests
- Payment confirmation
Documented Approvals
- Always audit ready
SOP Documentation
- SOP authoring/editing
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Project Planning
- Business Requirements
- Service Design Package
- Configuration Requirements
- Design Specification
- Validations
- System Requirements
- User Requirements
- Technical Installation Plan
- Test Plan & Test Cases
- System Access Plan
- Service Build Plan
- Document Management
- Quality Plan
Project Reporting
- Service Build
- Transition Report
- Decommissioning Plan
- Decommissioning Report
- Data Migration Plan
- Data Migration Report
- Third Party Audit Report
- Quality Report
- Test Report
- Installation Report
- System Release Notification
User & Technical Documentation
- Change Control
- Smart Controls
- GxP
- SOP
- GSOP
- Operations Manuals
- Technical Manuals
- End User Manuals
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SOP Generation, Project Management, & Strategy Deployment Service
- Lead/author creation of procedures, policies, job descriptions, etc.
- Assist clients to successfully grow from start-up to mid-size and beyond
- Conduct gap assessments, evaluate strategies and/or provide insights, etc.
- Project manage creation of reports
Auditing, Inspection Prep, & Quality Monitoring
- Perform GCP and PV Audits and Mock Inspections to help clients meet regulatory obligations
- Implement QC checklists, in-quality reviews, create quality monitoring plans
Aggregate Reports & Risk Management Plans
- Authoring Risk Management Plans and aggregate reports such as:
- Development Safety Update Report (DSUR)
- Periodic Benefit Risk Evaluation Reports (PBRERs)
- Investigational New Drug (IND) Annual Reports
Clinical Services
SAE reconciliations, Tracking of submissions to HAs and sites/Ethics Committees/IRBs- Coordinate and carry out safety activities in clinical trials. For example: Monthly Reconciliations of safety reports across different clinical Contract Research Organizations (CROs). These essential activities demonstrate compliance and adequately sponsor oversight by Safety and Clinical Operations plus are burdensome (require dedicated staff)
Regulatory Intelligence Monitoring
- Collect and analyze HA websites for PV Regulatory information
- Incorporate other tools such as Cortellis and Tarius for PV regulatory information
- Provide impact assessment
- Periodically monitor and update the tracking of this information
Signal Management
- Conduct signal detection activities, author/draft responses to Health Authorities on specific ad hoc safety requests
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Time Management
- Increase the amount of time available for internal IT staff to concentrate on strategic projects, short and long-term planning, and other IT infrastructure improvements
Staffing Efficiencies
- Allow for flexibility so IT staff can go on personal leave without sacrificing daily IT support and compromising end-user support
Monitoring & Support
- Provide “Peace of Mind” that any IT issues related to the covered systems will be addressed quickly, proactively, and without any delay using the most modern network, server, and desktop monitoring tools available
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Reporting
- Agent KPI Scorecard
- Agent Call Evaluation Form
- Volume & Workload Distribution
- Desk Occupancy & Forecasts
- Dynamic Reporting
Dashboard Creation
- Case Metrics Per Region
- Call Metrics Per Region
- Global Metrics
Scheduling Optimization
- Staffing Needs
- Labor Laws
- Workloads & Availability
- Shift Preferences
- Operations Research
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BCP/DR Planning
- Critical Systems Identification
- Employee Communications
- Media Communications
- Escalation Plan Development
- Communication Plan Development
- Risk Management Assessment
- And More!
Crisis Management
- Business Requirements
- Staffing Requirements
- Incident/Crisis Classification(s)
- Crisis Response Planning Plan
- Risk/Cost Benefit Analysis
- LA/KPI Requirements
Deployment
- Activation With LA/KPI Driven Response
- Introductory Training
- Quarterly Refresher Training
Crisis Management Close-out
- Ramp-Down Per Business Requirements
- “Return To Normal Operations” Plan
- Modification/Updating Of Crisis Management Plans
- Post-Event Training
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Tailored Globally, Integrated Seamlessly
We’re the experts that provide life science organizations the tools to properly and efficiently document processes, procedures, and responsibilities.
Connect Employees, Streamline Processes, Exceed Expectations
Data-Driven & Customized
For tailored reports and custom dashboards that outline core business opportunities and allow you to visualize real-time metrics, partner with Alphanumeric. In-house solutions allow you to track the customer at scale.
Success Story: Empower Patients & HCPs with Technology
Integrated Solutions That Work
Designed to help our clients achieve complete end-user satisfaction and enhance workforce productivity, Alphanumeric is equipped to learn the ins and outs of your current systems and optimize them.
Expert Support for Technical Areas
Employed by a team of business analysts, technical authors, documentation specialists, and subject matter experts to help your business achieve its goals – it's at the heart of what we do.