Patient Services Compliance Assessment & Support
CASE STUDY ONE
Patient Services Compliance Assessment & Support
CASE STUDY ONE
Challenge
Industry wide, Patient Support Services Programs are receiving more attention, legal scrutiny and activity from government and other entities. A leading biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases wanted to evaluate its program for risk of litigation and investigations in various areas.
Approach
Assessed current program documentation and created process flows to detail current state of functional areas and responsibilities by stakeholder.
Created documentation roadmap including prioritization chart of new program recommendations including timing, level of effort, and potential cost of addressing each.
Developed necessary policy and standard operating procedure document for key Patient Services areas and activities.
Created training presentations and facilitated for the Patient Services Support group.
Impact
Following the key stakeholder interviews and associated assessment, Helio rapidly delivered an approach to addressing the missing policy and procedure documents, created the agreed upon documentation, and ensured all necessary stakeholders and team members were trained to ensure the mitigation risk of non-compliance with internal policies and external regulations.
Data Governance & Business Strategy
CASE STUDY TWO
Data Governance & Business Strategy
CASE STUDY TWO
Challenge
A top 5 pharmaceutical company tasked Helio with providing next generation strategic planning of innovative digital platforms. Focusing on the growth of the Patient Services area, the objectives of the project were to analyze regional capabilities, competencies and compliance needs and to optimize model and governance structure.
Approach
Next generation platform strategy
Focus on strategic planning services provided
Analysis of patient services workflow processes and technology
Real World Evidence program set-up and execution
Social media vendor analysis
CRM integration
Impact
Helio increased the transparency into objectives, intended outcomes, and planned/actual benefits over time. In addition, we engaged C-suite sponsors to develop a clear path for decision-making and endorsement as well as streamlined and accelerated implementation of new capabilities and realization of benefits.
Alignment & System Integration
CASE STUDY THREE
Alignment & System Integration
CASE STUDY THREE
Challenge
A world leader in the manufacturing of generics and biosimilars was acquired by a larger pharmaceutical company and required assistance in the consolidation and integration of all previously used systems related to data tracking and spend reporting and the existing systems across both organizations. The timeframe for project completion was extremely tight as reporting deadlines were fast approaching.
Approach
Performed gap assessment of existing systems and procedures.
Facilitated and led joint process mapping meetings between organizations.
Developed business requirements and supporting system matrices for purposes of transition.
Created applicable test scripts and performed all necessary user acceptance testing.
Created and executed training and all change management across organization.
Produced all associated standard operating procedure documents and work instructions.
Impact
Helio's project provided our client with a successful transition of all systems and associated data as well as to provide them the necessary resources to report for federal and state-wide requirements in a timely fashion.
Global Transparency Assessment & Implementation
CASE STUDY FOUR
Global Transparency Assessment & Implementation
CASE STUDY FOUR
Challenge
As global spend reporting requirements continue to evolve into official legislation and with each country implementing unique reporting specifications, a leading global specialty biopharmaceutical company tasked Helio with assessing its overall program and approach to Global Transparency, specifically, its European entity. The focus of the project was on international expenditures for healthcare professionals (“HCPs”) and healthcare organizations (“HCOs”) in accordance with requirements of international disclosure laws and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code.
Approach
Conducted assessment of Global Transparency procedures and requirements.
Through interviews and program review, Helio identified pain points and reporting gaps, while also validating client priorities and establishing guiding principles for design of the future program.
Identified operational and structural gaps in processes and systems.
Prioritized and organized remediation of gaps by level of effort and complexity.
Developed implementation “roadmap” and outlined high level business requirements.
Managed risk factors by establishing organizational structure and creating timeline of prioritized tasks.
Impact
By compiling all identified gaps and accompanying recommendations, Helio developed the necessary roadmap to ensure compliance and aligned efforts with strategic partners to drive future program enhancements implementation. The team provided the client with a clear path forward to building a more functional Global Transparency program which will ensure complete and accurate reporting for all relevant country laws and regulations.
Internal Process Development for Customer Engagement Compliance Operations Team
CASE STUDY FIVE
Internal Process Development for Customer Engagement Compliance Operations Team
CASE STUDY FIVE
Challenge
A top 5 pharmaceutical company had an immediate need to overhaul its domestic and global customer engagement operations as it noticed significant gaps and inefficiencies as it related to its processes and associated systems. The client tasked Helio with evaluating the current state global research & development customer engagement process as well as develop a future state strategy related to global customer engagement Compliance operations.
Approach
Conducted key stakeholder interviews and developed thorough gap analysis and prioritization chart.
Created detailed process and system architecture maps to illustrate transition to the future state of the program.
Upon gathering input on each stakeholders’ priorities, Helio facilitated workshops to determine prioritization for each next phase and communicate a view of what is possible based on budget, timelines, and inter-dependencies.
Leveraged deep experience in program management, vendor management, and organizational change to prioritize and coordinate project efforts.
Impact
By providing the client with a concise and actionable roadmap, Helio enabled the enhancement and updated design of the global customer engagement Compliance operations. Helio fostered efficiencies and project cohesiveness across the entire program, which was essential for a successful and cost-effective implementation.
Market Research Analytics
CASE STUDY SIX
Market Research Analytics
CASE STUDY SIX
Challenge
A specialty pharmaceutical company was looking to identify treatment areas where transdermal drug delivery system (TDDS) options could enhance and improve the drug delivery options over existing therapies. The company desired to exceed stakeholder (e.g. healthcare professional and patient) requirements and address possible opportunities and challenges utilizing current and future form of TDDS technology.
Approach
Conducted a situational assessment to understand the client’s understanding of the transdermal patch market and to determine metrics in the market analysis.
Performed a proprietary data-driven analysis by leveraging an algorithm-based text analytics engine to identify the universe of potential disease states and determine assessment parameters.
Validated research findings utilizing targeted primary research.
Impact
The client received a comprehensive analysis of all therapeutic categories where TDDS had the potential to be a successful delivery mechanism ranked by commercial attractiveness and looking at both current and future state of TDDS technology. With the findings, the client was able to uncover a niche rare-disease therapeutic area based on the information provided and has integrated findings into overall business development planning.
Federal & State Transparency Filing Support
CASE STUDY SEVEN
Federal & State Transparency Filing Support
CASE STUDY SEVEN
Challenge
A small biopharmaceutical company struggled to comply with the annual Federal and State Aggregate Spend Reporting requirements as it did not have the expertise or resources available to do so. Over the course of the last 3 years, Helio has annually been tasked with data collection, review, remediation, and report generation to ensure the client remains compliant with all relevant laws and regulations.
Approach
Compile all spend data from associated spend owners and source systems.
Review data for accuracy and completed including the identification of data inconsistencies and errors.
Facilitate review with stakeholders and system owners to remediate data where necessary.
Produce and file all necessary reports to respective Federal and State governing bodies.
Assist in the examination all of spend disputes as well as any associated resolution activities.
Impact
As a direct result of Helio's work, the client now has a reliable and consistent framework to compile, review, and report all applicable Federal and State Transparency data annually.