01Literature & Systematic Reviews
PHSR Consulting supports the identification, selection, critical appraisal, quality assessment and analysis of the best available evidence on research questions in line with credible research guidelines on the conduct and reporting of literature and systematic reviews such as CRD, COCHRANE, PRISMA.
02Health Technology Assessment
We support the conduct and execution of HTAs across geographies including both the clinical and cost effectiveness evidence to inform dossier development. The HTAs are developed in line with the country requirements of reimbursement bodies such as NICE, AIFA, ANSM, AMNOG, etc.
03Real-World Evidence Studies
We plan, design and execute Real-World Evidence (RWE) studies through observational research relative to a range of study designs i.e. chart reviews, database analyses, PROs, etc. Real world evidence is generated from evidence sources beyond clinical trials and thus, is increasing being recognised as a major component to inform reimbursement decisions across therapeutic areas.
04Network Meta-analysis/ITC/MAIC
We use these techniques to compare multiple treatments simultaneously in a single analysis by combining direct and indirect evidence within a network of randomised controlled trials as well as real-world estimates, where applicable, based on common comparator(s). Information generated from pooled analyses can inform GEVD development, HTA submissions and facilitate decision making on product strategies.
05Consultancy and project management
In line with our client’s business needs, we provide our services on a consultancy basis and tailor level of interaction depending on the ask. Additionally, we support project management including cross-functional alignment with both internal and external stakeholders to support the execution of the project at hand.
06Guidelines
Using both published and unpublished evidence, we support the conduct and delivery of local, national and international guidelines across therapeutic disease areas in line with our client’s business needs. We also support the publication of these guidelines to inform clinical and policy making decisions.
07Training
We offer and tailor training services to suit business needs such as short cases on literature searches, critical appraisal, methodological conduct of HTAs, design and set up of RWE studies and medical writing.
08Medical Writing, QC and Publication support
Any scientific report or document should be composed in a clear, concise, and compliant way conveying the scientific information without any ambiguity and misrepresentation. We support the writing and submission of publications to meet journal/congress/conference guidelines and advise on target journals to meet the methodologies of the studies at hand.
09Regulatory Support
We support regulatory activities such as drafting and coordinating Orphan drug application submission (ODD/ODAs) and Risk Management Plans (RMPs), both core and across targeted markets in line with advice from regulatory bodies such as FDA, MHRA and EMA.
