Our Consulting Services
HELIO offers a range of world-class professional services designed for the Life Sciences. We provide traditional compliance consulting forged from years of experience. But now we also provide new technologies to help you manage risk. We even offer some combination of the two: compliance services improved and enabled by innovative AI technology.
Transparency and Disclosure
Transparency and disclosure laws were created to increase transparency of the financial relationships between healthcare professionals and organizations and the pharmaceutical industry. Initially started in several states in the U.S. and expanded federally, these disclosure requirements have expanded globally and made into law and/or incorporated into country-specific industry codes. HELIO helps companies navigate the operational complexity of aggregating data related to expenditures and ensuring thorough and accurate reporting of these relationships.
Services include:
Global & U.S. Transparency Reporting
Program Optimization & Implementation
Data Verification
HCP Dispute Process & Resolution
Policy & Procedure Development
Assistance in Manufacturer & Field Force Annual Registration & Licensing Requirements
HCP Engagement Compliance
Interactions with Healthcare Professionals are a key Life Science business activity, but can be risky without the proper guardrails in place. HELIO provides clients with the structure, processes, and tools to mitigate kick-back risks and ensure compliant interactions and engagements with HCPs via Needs Assessment Processes, Compensation Tracking Tools, and Fair Market Value (FMV) services.
Services include:
Policy & Procedure
Needs Assessment Process
Compensation Tracking
FMV Methodology & Tiering
FMV Rate Refresh
FMV Calculator Builds
Compliance Operations, Advisory Support & Change Management
HELIO helps clients with their operational and advisory support needs in order to run, develop and enhance their Compliance programs. Support includes providing staff augmentation to Compliance teams, creating and delivering general and specified compliance related trainings and communications, and providing high-level advisory services to enhance Compliance programs and operational activities. Now, with HELIO AI, you can identify, track and contact Covered Persons under CIAs and DPAs.
Services include:
SME Advisory Services
Corporate Integrity Agreement (CIA) Readiness & Support
Project Management
Staff Augmentation
Compliance Training Creation, Delivery, and Implementation
Communications and Change Management
Monitoring & Auditing Program Development & Execution
To ensure the effectiveness of a Compliance Program, companies utilize Monitoring and Auditing of activities to test against their established policies and procedures. HELIO assists in the design of annual monitoring plans, defining monitoring parameters, and the execution of monitoring and auditing of risk-prioritized activities. Now, with HELIO AI, you can more easily and immediately track and respond to patient transactions, communications and forms.
Services include:
Risk Evaluation & Risk Based Identification
Program & Plan Development
Technology Platforms for Monitoring & Auditing
Monitoring Form Creation
Records Reviews/ Desk Top Review
Live Monitoring
Data Analytics
AI Solutions Strategy & Implementation
HELIO has been a leading innovator in self-learning technology for nearly a decade. We will audit and analyze your existing GEN AI set up, making sure it meets best practices and is optimized for performance. We can also offer our own suite of GEN AI products to help you manage your Life Sciences business better and more efficiently.
Services include:
Current State Technology Analysis
Future State Roadmap Solution
Discovery, Configuration, and Testing
GenAI Change Management, Training, Roll-Out and Post Go-Live Support
Systems Implementation Change Management, Training, Roll-Out and Post Go-Live Support
Government Program Advisory & Managed Services
This service area has expanded greatly as the importance of Government Programs has grown. Our experts will help you manage the complexities of pricing and compliance in Medicare, Medicaid, and Veteran Affairs.
Services include:
GP Compliance Assessments and GP Enhancement
Class of Trade and 340B Validation
Bona Fide Service Fee and Fair Market Value
GP Recalculation
IRO and CIA support
Product Master Reconciliation
Government Program Enrollment & Pre-Launch Support
Compliance Governance Documentation
At the backbone of every Compliance Program is governance documentation that details the expectations and requirements for conducting business activities and interactions in a compliant and ethical manner. HELIO helps clients to develop and update key Compliance governance documentation including Policies and Standard Operating Procedures, as well as work instructions, call scripts, and FAQs. HELIO also assists with the dissemination and implementation of these documents to ensure availability and understanding throughout the business. Now, with HELIO AI, you can get immediate policy information and identify gaps in policies and procedures.
Services include:
Policy/SOP Creation & Update
Industry Best Practices Advice
Industry Code Updates
Call Scripts, Guidelines, and FAQs
Process Flows
Roles & Responsibilities, Job Descriptions
Patient Services Program Compliance
Industry-wide, Patient Support Programs are receiving more attention from government and regulatory entities, and it is imperative that companies understand the associated Compliance risks when engaging with patients and avenues provided to improve patient access to their products. HELIO provides insights and operational strategies as to how companies can implement effective controls within their Patient Support Programs.
Services include:
Compliance Review
Governance Model Development
Patient Case Note & Communications Review
PSP Vendor Review/ Audit
PAP Audits & Patient Case Audits
Compliance Program Assessment & Enhancement
HELIO’s Compliance Program Assessment and Enhancement services focus on crafting best-in class Compliance Programs. This includes creating Compliance Programs for companies who are in a pre-launch phase and assisting established Life Sciences companies with a risk/gap assessment of their current program and optimizing their program to mitigate risk. Now, with HELIO AI, you can identify Compliance-related questions and get real time answers regarding HCP interactions.
Services include:
Program Creation (Pre-Launch)
Risk/Gap Assessment
Program Optimization & Risk Mitigation
RAMP
RAMP is short for Risk Assessment & Mitigation Plan. This traditional consulting service is now Tech Enabled with HELIO AI to help you proactively identify areas of risk, streamline compliance processes, and maintain regulatory alignment with greater confidence. Having experts oversee the RAMP while utilizing technology to process more data and information increases the overall analysis, which is crucial for understanding risk across the enterprise, regions, and functions.
Services include:
Compliance Review
Governance Model Development
Patient Case Note & Communications Review
PSP Vendor Review/ Audit
PAP Audits & Patient Case Audits