capsulation consulting brochure

www.capsulation.co.uk [email protected] +44 (0) 20 8551 2901

We are able to deliver projects within the domains of regulatory affairs, health outcomes research and bio-statistical modelling. With access to technical resources and industry specific software, our expertise adequately supports even the most challenging of projects within the pharmaceutical sector.


Our experience in the delivery of global HTA submissions (UK, EU, US) is now further supplemented with value dossiers for the emerging markets, including expertise in the formulation of medical device regulatory reports.

Business impact analysis, with health economic modelling has been added to our exiting statistical reports. Ratified by clinical, payer and marketing specialists, this builds on the clinical trial data analysis (phase I-IV) reports that are combined together by our medical writing specialists.

Our landscape assessment ensures a thorough subject-matter evaluation followed by academic endorsed systematic reviews. Pooled treatment effects in combination with a network of trial evidence complement reports that incorporate various techniques including regression and survival analysis.

Real world evidence in combination with trial data forms the basis of robust health economic analysis. We build regulatory compliant models using industry software (TreeAge) with statistical modelling coded within STATA.

Capsulation Consulting provides bespoke project solutions to the pharmaceutical and biotechnology industry. Close integration with our clients ensure your project adheres to the highest compliance and quality specifi-cations. Unlike agency contractors, we carry the full legal responsibility and are liable for all deliverables as per business agreements.

With a project based pricing structure, you’re not left to artificially constrict the time allocation for a project thereby compromising it’s quality. This allows the delivery of high quality, industry compliant projects on the face of budgetary constraints imposed by the current economic climate.

Our innovative networks strengthen our partnerships with academics, industry professionals and key opinion leaders. Your project is delivered by the collaborative approach provided by a unique blend of management and technical expertise through our multi-disciplinary team ensuring complete client satisfaction. Our standard post-delivery customer care can be further extended ensuring complete project control.

Hiring individual consultants are frequently outweighed by the potential disadvantages of outsourcing project work. Higher associated costs, poor ROI, lack of quality, loss of business continuity and limited project control can quickly write off the experience.

At Capsulation our re-designed client facing products are now more flexible to your needs having the involvement of key professionals within each phase and still remaining extremely value for money. Being smaller in size, we are able to provide a personal touch; something highly appreciated by our clients. Contact us to learn more about this journey to innovative consulting, and how we can help you on your project deliverables.


Capsulation consulting provides an exclusive approach in consultative services to the pharmaceutical, biotechnology, medical devices, clinical research organisations and the healthcare industries with client-facing, industry compliant, high quality project deliverables at a fraction of the existing market costs.

The current financial climate necessitates all clients involved in the business of healthcare incorporate an alternative, economically viable provision for managing their business. Our close association with industry professionals, academicians and key opinion leaders enables us to deliver quality projects at lower than current market costs.

We have invested more in system resources and our people, which along with our costs saving strategies has assisted in passing this benefit to our clients. Ultimately every penny counts, even more so when it comes patient’s lives.

Our lead clinicians are both consultants in the NHS and academics at leading universities. With professional backgrounds in pharmacovigilance and health economics, their clinical input is crucial in formulating our clinical trial reports and value dossiers.

Our managing director comes with over 15 years of pharmaceutical experience. With qualifications in medical genetics, translational medicine and public health medicine, his leadership has enabled us to deliver highly challenging projects above and beyond our client expectations, placing us as a key stakeholder with NICE.

Our medical writers are closely linked to the biotechnology and the pharmaceutical industry. Their strong technical expertise is essential in formulating reports in peer reviewed journals, and are essential for our systematic reviews.

Our clinical trials management involves our key medical statisticians, who work closely with the research councils. Our complex modelling work pays homage to their input alongside our health economists who add flavour to our budget impact models.

We work closely with partner organisations providing us with pharma-vigilance, licensing and regulatory affairs support. Our application developers are key to the production of interactive application tools, an area which we are further developing.

Detailed team profiles can be found on our website www.capsulation.co.uk

DATABASES

SOFTWARE


Our network of technical professionals in combination with our in-house resource provide you with topic specific training modules. With specifications covering your requirements, our training is designed to provide maximum interactive engagement; hence delivered on-site enabling our client to gain maximum value in terms of practical applications of the learning outcomes to real-world situations.

Our network meta-analysis methods are industrial research compliant and supported by lead academics. With PRISMA adherence critical to our systematic reviews, we provide full statistical analysis plans, design protocols, database search strategies along with complete management of the technical appraisal process. Our systems are designed to work in tandem with client specific software systems as well.

We provide an extensive portfolio of services to you that require the use of leading software solutions. STATA, TreeAge, WinBugs, ADDIS, RevMan, and EndNote - some of the approved software solutions that we use to formulate our client requirements. Our partnership with a leading pharmaceutical application developer completes the full-service offering, removing the need for multiple consultancy allocation.

Capsulation through it’s extensive collaborations has managed to secure access to most leading resources (peer journals) and healthcare related databases. Our interrogation methodology in combination with databases that we search are the best in the industry; we even have access to key local area health information through our dedicated network professionals.

We are constantly updating our access features, so if you don’t see a database, give us a call or email us and we’ll be happy to support.

DATABASES

KEY FEATURES

MODULES

Drug development processProduct life cyclesRegulatory licensingMarket access & HTAsOrphan drugsClinical trial designsStatistical analysis of trialsRare disease characteristicsMarket approval vs accessClinical challenges

PRISMA complianceStatistical analysis planFull network meta-analysisIndustry approved processConstant client updateProject tracking systemsFull-service offeringFree project scopingGuaranteed market price

STATATreeAgeWinBugsADDISEndNoteMeta-analystR (statistical package)

PubMedMedlineEMBASEFull OVID professionalProQuest HealthCochrane (full system)CRDJAMABMJEBSCO


Our industry experts have extensive experience in developing bespoke client facing global value dossier packages. Our value products are essential in supporting HTA submissions along with further reimbursement negotiations.

Combined with payer research and evidence assessment, we combine cost-effectiveness models with budget impact analysis in developing a robust value communication tool supported by evidence based medicine.

Case study

Our client required a GVD for an existing therapy to be used for another clinical indication, indicating that the GVD would support both reimbursement submissions and value based discussions, as well as communicate in detail the value of the therapy.

Our conducted evidence review identified some key value propositions, supporting the client’s intentions for allocating a full GVD development programme. Our close client liaison identified and established a core group of representatives who provided review support to the GVD from the client’s perspective.

The final GVD has become a central repository of core value based evidence, which requires periodic updates by us, thereby supporting country affiliate negotiations. Our eGVD has not only met the client’s demand, but has also been provided to the client significantly ahead of the schedule of requirements.

Case study

Our client required a quick market access review to support a legacy medical device that required regulatory submissions to the EU regulators. The device had approved usage in the USA. The client required opportunity prioritisation and an evaluation of any value barriers.

We processed a review of reviews, analysing both the clinical effectiveness and the economic value of the device. Subsequent interviews with KOLs identified possible barriers and opportunities for reimbursement.

Our research clearly demonstrated to our client the unmet need within the indications requiring the application of this device. Country specific recommendations for each indication based device application were provided in the form of clinical and economic evidence, the potential for reimbursement and the estimated size of the market, delivered as a comprehensive eGVD.