SWISS APPROVAL HEALTH CARE & MEDICAL TECHNOLOGY ASSESSMENT
SWISS APPROVAL HEALTH CARE & MEDICAL TECHNOLOGY ASSESSMENT
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Evidence generation

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Evidence Generation Strategy Development and Operationalization Services

Aim to devise and execute effectively an evidence generation strategy, that will support optimal price, market access and commercialisation, based on robust internally produced proprietary and externally sourced, curated and linked Data.

The Data are synthesised with vigorous methodologies to yield compelling evidence regarding the burden and management of disease and the utilisation, safety, efficacy, effectiveness, cost and other outcomes of therapy, to demonstrate to different decision makers, at International, National and Regional level.

The Evidence Generation Strategy is developed in a convincingly meaningful, relevant and customised manner, taking under consideration the size of unmet medical and economic needs, as well as the value of new product for stakeholders, including patients and their relatives, payers, providers and the overall society structure.

Our 5 Steps Process for Evidence Generation

Critical Client Task

  • Regulations: Monitor, analyse, understand and foresee evolving trends and standards in data, methods and HEOR evidence used for pricing, reimbursement, product market access and commercialisation of the business stream.
  • Stakeholders: Map important HEOR, P&R, and HTA thought leaders and stakeholders, understand and foresee their priorities, thinking, requirements as well as their needs.
  • Competitors : Monitor, analyse, understand, foresee and benchmark against competitors, in terms of access to data, methods and skills, infrastructure, management and evaluation tools, as well as external networks in therapy areas of interest.
  • Evidential Requirements: Understand evidential requirements as well as business and operational data, needed to support successful P&R, market access and commercialisation.
  • Real World Data: Locate external real-world data sources and assess them for relevance, content, access, quality, and cost in therapies of interest.
  • Policy: Shape methodological standards and data requirements with thought leadership work undertaken together with external partners.

Services We Provide

  • Regulations: Landscape reviews and assessments on P&R, MA, HE&OR, trends and data and evidential requirements, through desktop research, stakeholder surveys, advisory boards and workshops and development of insights.
  • Stakeholders: Stakeholder mapping studies, intelligence collection, analysis of needs and wants, through desktop research, stakeholder surveys, advisory boards, and workshops.
  • Competitors: Competition intelligence, benchmarking and analysis; assessment of opportunities and risks and risk mitigation analysis through desktop research, stakeholder surveys, advisory boards and workshops and development of insights.
  • Evidential Requirements: Review and assess data generation programs against the evidential P&R and MA requirements, the TPP, HTA body standards, and competition to identify data gaps.
  • Real World Data: Reviews to identify, classify and assess real word data sets in selected therapy areas and verify conditions and cost of accessibility.
  • Policy: Map and recruit experts, co-undertake thought leadership research to shape methods; organise advisory boards and workshops and write papers and produce presentations.

Critical Client Task

  • Alignment: Coordinate with other business functions and integrate activities related to health economics, outcomes research and evidence generation, into functional and cycle domains, which will guide to the related strategic and tactical plans.
  • Capacities: Assess internal organisational capacities, experience, gaps, and priorities at global, regional and national level and plan to cover any weakness and gaps.
  • Engagement: Engage with important stakeholders in relevant pricing, reimbursement, health technology assessment, payer and governmental agencies, and in academia in the HEOR field.

Services We Provide

  • Alignment: Facilitate cross functional alignment through workshops; Review and provide input into the development of the regulatory, medical, market access, pricing & reimbursement, governmental & advocacy affairs and brand plans.
  • Capacities: Review, benchmarking and assess internal organisational capacities. Provide advice, training and support to cover weakness and gaps at different company levels.
  • Engagement:Identify and select experts in relevant agencies and organisations, develop networks and engage effectively through scientific and other relevant activities aiming to establish trusted relationships.

Critical Client Task

  • Strategy: Develop cross functional evidence generation strategy. Develop and approve plans to support pricing, reimbursement, market access, and commercialisation. Analyse and evaluate operational and functional feedback.
  • Clinical Program: Ensure that clinical development programs collect appropriate data to capture product value and optimise chances for success.
  • Real word data: Select and source external real word data to generate the evidence needed for the implementation of the data generation plan.
  • Patient Outcomes: Plan, if needed, development of new QoL and PRO instruments to capture in full product value in the context of clinical and real-world studies.

Services We Provide

  • Strategy: Review data generation plans and advice on evidence generation strategy needed to attain optimal prices and early market access and commercialisation of technology at different systems and business setting.
  • Clinical Program: Review study protocols. Comment on data collected on clinical and patient reported outcomes, resource utilisation, populations, and competitors.
  • Real word data: Select and source external real word data needed to generate the evidence needed for the implementation of the data generation plan.
  • Patient Outcomes: Undertake reviews, translate and validate or develop new QoL and PRO instruments to capture in full product value in the context of clinical and real-world studies.

Critical Client Task

  • Unmet Need: Generate evidence on the epidemiology, the natural history, and the burden of disease and highlight potential unmet clinical and humanistic needs.
  • Practice: Generate evidence on the management of patients, real world product utilisation and place within treatment paradigms, and adherence to guidelines.
  • Real word performance: Generate evidence on real world product performance in terms of safety, effectiveness and cost, based on prospective or retrospective data.
  • Patient reported outcomes: Generate evidence, on patient reported outcomes, quality of life, experience and preference, based on multi criteria decision analysis.
  • Product development: Undertake exploratory analyses on new patient populations, new settings, administration modes and doses and determine evidence gaps for running meaningful comparisons.

Services We Provide

  • Unmet Need: Undertake epidemiology surveys and studies on the burden of illness either based on prospective or retrospectively collected real word data.
  • Practice: Undertake drug utilisation and adherence studies, based or prospective or retrospective data collection. Analysis of designs, patient or physician data & motion studies.
  • Real word performance: Undertake outcomes [safety, effectiveness, cost] studies, based or prospective or retrospective data collection and analysis.
  • Patient reported outcomes: PRO/QoL/COA instrument development, validation and measurement studies; Patient preference, contingent valuation and multi criteria decision analysis.
  • Product development: Undertake analytical, simulation, econometric, statistical modelling of data in from trials, claims databases, registries, charts, electronic patient records, social media, observational studies, population surveys and other sources.

Critical Client Task

  • Knowledge augmentation: Generate robust, meaningful data to back cross country and life cycle pricing, reimbursement, market access, and commercialisation plans; support technically negotiations with stakeholders for optimal results.
  • Infrastructure: Train, guide and support staff; develop corporate internal infrastructure and skills; integrate evidence generation to functional domains and develop alignment.

Services We Provide

  • Knowledge augmentation: Support client strategy and execution with tailor made analytics, report and model customisation's. Reporting, advisory work, presentations, internal facilitating workshops, reviews, insights and intelligence.
  • Infrastructure: Undertake bespoke training on soft and technical skills development; give advice on organisational issues and capacity development; organise internal brainstorming and alignment workshops; facilitate cross-functional collaboration.

We are an impartial and independent market access and business development services firm, branch of Swiss Approval International, specialised in the Health Care and Life Science business.

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