Transform Your Business with Our Expert Services

We support pharmaceutical, biotech, and MedTech companies in designing robust, globally-aligned evidence-generation strategies that meet the expectations of regulatory and HTA bodies. From early pipeline through to launch and beyond, we help ensure that clinical and economic evidence is tailored to demonstrate product value in real-world settings. Our strategic frameworks account for country-specific HTA guidelines, payer archetypes, and evolving policy landscapes. We are fully prepared for the EU Joint Clinical Assessment (JCA) process, offering ready-to-implement planning pathways that align with JCA requirements and timelines—ensuring a future-proof evidence package from day one.

We specialize in delivering high-integrity evidence syntheses to inform reimbursement, regulatory submissions, and strategic decision-making. Our systematic literature reviews (SLRs) are conducted in accordance with internationally accepted standards (e.g., PRISMA, Cochrane, NICE), enabling seamless integration into HTA dossiers and peer-reviewed publications. We also provide targeted and rapid reviews—highly tailored, time-sensitive deliverables that support portfolio prioritization, in-licensing evaluations, and internal clinical strategy. With advanced data management tools and quality control processes, we ensure reproducibility, transparency, and speed.

We provide advanced statistical expertise in conducting indirect treatment comparisons (ITCs), Bucher analyses, and network meta-analyses (NMAs), essential for comparative effectiveness research. These analyses support HTA bodies, payers, and clinical stakeholders in evaluating the therapeutic value of your product relative to competitors. We utilize best-in-class statistical software and follow guidelines such as ISPOR and NICE Decision Support Unit (DSU) recommendations, ensuring methodological rigor, reproducibility, and credibility in high-stakes submissions and publications.

Our health economic modeling services provide powerful tools to demonstrate the value and cost-effectiveness of interventions across diverse healthcare systems. We specialize in the development and country-level adaptation of core economic models, including cost-utility, budget impact, and cost-effectiveness analyses. Whether it’s a de novo model or adaptation of a global model to local payer needs, we ensure methodological soundness aligned with HTA agency requirements (e.g., NICE, IQWiG, CADTH, HAS). Our models are transparent, scalable, and designed to support both strategic decision-making and payer engagement.

We develop fully compliant Clinical Evaluation Reports (CERs) for medical devices, tailored to meet the European Medical Device Regulation (EU MDR) and global regulatory standards. Our CER development process includes comprehensive literature review, appraisal of clinical data, risk-benefit analysis, and alignment with GSPR and MEDDEV 2.7/1 Rev. 4. With experience across diverse device classes and therapeutic areas, we ensure timely, audit-ready documentation to support successful regulatory submissions and Notified Body assessments.

We provide integrated pharmacovigilance solutions across the product lifecycle—from clinical development through post-marketing surveillance. Our services include safety signal detection, aggregate report writing (DSURs, PSURs/PBRERs), risk management plans (RMPs), literature surveillance, and case processing in compliance with GVP modules and global regulatory frameworks (EMA, FDA, PMDA). Our pharmacovigilance experts help clients ensure regulatory compliance while proactively managing product safety to protect patients and reputation.

We deliver strategic medical affairs support, blending scientific excellence with communication impact. Our services span integrated publication planning, manuscript development, congress content (posters, abstracts, oral presentations), scientific slide decks, and medical education tools. We also support Key Opinion Leader (KOL) mapping and engagement, advisory board execution, and CME program design. With experience across therapeutic areas and launch stages, we help ensure scientific messages resonate with clinical audiences and reinforce your product’s value proposition.

Our competitive intelligence services equip clients with deep, forward-looking insights into competitor pipelines, market activities, and strategic positioning. Using a blend of primary and secondary research, we deliver real-time intelligence across clinical development trends, trial design benchmarks, regulatory pathways, pricing strategies, and market access approaches. Services include:

• Conference Intelligence (pre-, on-site, and post-analysis)

• Pipeline Surveillance

• Clinical Trial Landscape Mapping

• Patient Journey and Epidemiology Landscaping

• Therapeutic Trend and Technology Scanning

These insights power strategic planning, differentiation, and proactive risk management.