Clinical Operations & Medical Affairs

Our experienced team of physicians and clinical research professionals assist in the planning, conduct, and evaluation of clinical trials. They can help you in design of sound protocols by advising on study endpoints, eligibility criteria, study assessment and design options, and writing protocol synopsis. Protocols are designed to address timely recruitment of patients, and a provision of sound answers to scientific questions. You will receive excellent clinical study oversight which is paramount for a successful, timely, and cost efficient drug development process.

The services we offer you throughout the clinical trial and drug development process include:

  • Medical management and oversight Medical monitoring, Project team and study site training and support, Protocol review and design, Site visits with F2F protocol discussions with Principal Investigators

  • Patient safety and eligibility review Medical data review and trend analysis, Safety signal identification, High quality and cost efficient medical data review, Clinical Study Report (CSR)

  • Innovating evidence generation Leading rapid-cycle, integrated evidence generation across HEOR, RWE, Phase IIIb/IV, and all other data, supported by microanalysis to tailor information to the needs of individual patients and improving patient lives across the product life cycle

  • Accelerating access to treatments Clearly articulating clinical and economic value (including data) to build trust with partners and accelerate access to treatment to ensure that the right patient gets the right treatment at the right time

  • Transforming and personalizing medical engagement Upgrading physician and patient decision making by engaging providers, patients, and others with tailored information that improves outcomes, supported by a reimagined insight-generation process

  • Stepping up internal medical leadership Providing strategic medical direction to organizations steering resources for maximum medical impact, injecting new capabilities, and upgrading performance at scale to create medical leaders who drive and shape the future of medical affairs and companies as a whole

We count with experienced well-trained clinical research and medical affairs professionals, including physicians, clinical research managers and supporting staff.

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Regulatory, Legal & Pharmacovigilance

Our regulatory specialists support you in all aspects of regulatory affairs and provide your company with what is needed to succeed in the pharma market. From advice and guidance, to full-spectrum regulatory support, our services focus on the following:

  • Registration & Submission Support – from accompanying documents to full dossiers and providing tailored documents for target markets, specific products or applications

  • Life-cycle Management of Regulatory Documentation – always ensuring quality & compliance standards

  • Consultancy & Knowledge Sharing – finding the best regulatory route to be successful or just keeping you up to date with regulatory matters

  • Comprehensive Legal Support – Legal Representation, Coordination with local authorities, Regular updates on relevant changes to EU legislation and/or local legislation, Liaison with Ethics Committees and Competent Health Authorities, Translation services

  • Pharmacovigilance – ensure compliance across the full product lifecycle for a broad range of product types

We support you in meeting the needs of your Business and all Regulatory, Legal or Pharmacovigilance requirements.

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Integrated Insights & Market Analytics

Our Integrated Insights & Market Analytics team identifies, projects, and quantifies the impact of competitive-landscape shifts in the pharmaceutical and biologic market, offering a range of differentiated services:

  • Product Life-cycle Analysis

  • Clinical, Formulary, Procurement, and Inventory-control Insights – payers, providers, and suppliers

  • Brand & Generic Market Impact Forecasts

  • Scenario Analysis & Budget Impact Models

  • Pharmaceutical Coding and Reimbursement Information

We work together with your team to deliver compelling insights and analytics to help you solve complex, multi-layered problems for better decision making.

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Market Access & HEOR – Health Economics and Outcomes Research

We provide flexible and integrated Market Access & HEOR services to organisations, balancing scientific rigour with commercial foresight. Our in-depth experience covers strategic and tactical support for evidence generation, implementation and value communication across disease areas.

  • Registration & Market Entry Agreement Introducing new products (DCP, RMP, National), Marketing authorization transfer

  • Evidence-based Market Access Solutions Systematic Review, Feasibility assessment, Meta-analysis and RWE – Real World Evidence

  • Reimbursement & Value Communication – Value/reimbursement dossier, Value Proposition Development, Medical Writing, Publication & Manuscripts, Objection Handlers

  • HEOR – Cost-effecfiveness models & BIMs – Budget Impact Models

Our services support teams and local market affiliates to prepare for the critical aspects of market access, including health technology assessment and local reimbursement at all key stages, from early phase to post-launch.

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Strategy & Business Development

We provide our strategic recommendations and business development activities to ensure our clients are able to maintain high sales volumes and stay profitable while fulfilling your costumers needs.

  • Market Potential Analysis & ForecastNew geographies, segments, adjacent markets

  • Selection of Key Strategic Growth Segments & Partners Identify, Build & Develop

  • Business Intelligence, Market Research & Risk management analysis

It’s our job to ensure that your company’s revenue pipeline is full of viable opportunities and accelerate growth for your organisation. We support you with in and out licensing and partnership opportunities, benchmarking key deals and patents, and trying to assess how the latest healthcare and pharma trends might affect your current and future business strategies.

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Marketing & Sales

We provide a unique range of marketing solutions to put you in touch with your clients. Whatever your objectives, we can help you to reach your target audience the way they want to be contacted

  • Stakeholder Mapping, Segmentation & Positioning

  • Marketing Plan Development & Implementation – Build Business Plan, Brand Management & Promotional Tactical Plan

  • Brand Awareness & Multi/Single Channel Promotional Campaigns

We leverage our expertise in the sector to assist you in planning content-rich marketing strategies and help every phase of a medicine, diagnostic or medical device’s lifecycle.

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Outsourced Project Manager, MSL – Medical Science Liaison & Sales Field Teams

We provide flexible outsourced field teams according to your needs independently if you are an SME Pharmaceutical/Biotechnology/Medical Device company launching your first product or a large, established company preparing to introduce your innovation into a new or competitive market.

  • Project Manager – supports marketing and/or medical teams with project management ensuring a timely delivery of key projects

  • Medical Scientific Liaison – Scientific peer-to-peer exchange, Clinical Trial support, KOL Management, Scientific Communication, Publications

  • Disease Area Specialist – Exclusive disease area scientific expert according to previous area of research and/or work
  • Sales Representative – Key account management, promotion and sales on Public & Private Hospitals, Primary-Care Centers, Private Clinisc, Community Pharmacy and Para-pharmacy

Our medical & scientific experts offer guaranteed high-quality peer-to-peer scientific exchange, clinical trial support and strong KOL stakeholder management. Our sales team is carefully selected, trained and deployed with strong key account management skills supporting you to deliver your promotional messages, achieving your sales targets and business goals.

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Distribution, Warehouse & Logistics

Our services include high quality storage and accurate distribution, acting as a primary distributor for companies linked to the area of medicine and health care, meeting the most demanding standards of the pharmaceutical industry:

  • Stock Management, Quality Control & Transportation

  • Labelling, Invoice Service, Track & Trace

  • CRM – Customer Relationship Management

We support you in meeting the needs of your Business and all Distribution, Warehouse and Logistics requirements.

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Transforming healthcare through disease prevention & control

 

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