European Studies and Articles

 

European Studies and Articles

Real-world evidence Europe | UBC
The current environment of tighter regulatory processes in relation to market access, combined with cost containment measures, has led to the increasing demand for post-market real-world evidence to demonstrate value. United BioSource Corporation (UBC) is a full-service provider...
• To summarize regulations regarding orphan drug designation in the US and EU • To discuss and demonstrate how drug developers can take advantage of the regulators’ incentives to optimize their investment in orphan drug development
Healthcare needs a hero | UBC
Biotech and pharmaceutical professionals typically don't get much recognition. That needs to change. It's time to shine a light on the heroes who walk among us, those who discover, develop and deliver life-saving medicine.
Pharmacogenomics whitepaper | UBC
Pharmacogenomics enables us to predict how an individual’s genes will affect his or her response to specific therapies. The role of pharmacogenomics is particularly significant to oncology, as tailored therapies maximize effectiveness and minimize adverse events. With experience...
Proactively manage risks and uncertainties in signal detection, strengthening, and refinement.
Post Haste - Jess Sohal - International Clinical Trials
Providing vital real-world safety information on a launched drug, post-authorisation safety studies can be key to market acceptance and uptake – but detailed operational planning is essential
Infographic: Rare Disease Patients Have Many Questions
Do you have the right answers for patients with rare diseases? UBC can help with our comprehensive services.
UBC Observational Studies - Europe
UBC offers strategic, scientifically rigorous studies designed to address stakeholder-driven evidence requirements. UBC is an industry leader in the design and global implementation of observational cohort studies, registries, large streamlined studies, other observational...
Quantifying increased efficiency with medical interventions
PASS brochure | UBC
UBC is an industry leader in designing and conducting post-authorisation safety studies (PASS) in Europe. Our staff combines deep scientific knowledge with industry and regulatory experience to design PASS protocols for both mandated and non-mandated PASS.
Feasibility Studies for Clinical Trials
More than just doing the groundwork before a trial starts, a preliminary feasibility assessment can be an important early indicator of site capabilities, study variables and potential hurdles – a reality check enabling sponsors to make changes while they still can
UBC is a leading provider of Risk Management services. Our experts have designed, implemented and evaluated more than 100 RiskMap and REMS programs, giving them a firm understanding of FDA and EMA requirements and the similarities and differences between the two. We consult with...
We offer customised consulting, development and implementation solutions in clinical development and late stage research. This includes experts on the ground in the EU who can assist with clinical trials, peri & postapproval studies and value demonstration programmes. Our...
Task-based Versus Case-based Analysis of Time Outcomes in Multi-country Time and Motion (T&M) Studies: Methodological Considerations and Application
Time-based variables are challenging due to numerous sources of variability and potential confounding, including but not limited to, individual site characteristics, inter-rater variability, characteristics of personnel being observed, as well as selection bias and residual...
In-patient Hospital Costs of Stroke: A Focused Literature Review
Stroke is the 3rd leading cause of mortality worldwide, and is associated with enormous economic burden. The acute phase of stroke treatment is associated with significant hospitalization costs.This poster reports on the published costs of stroke over the past 5 years and...
Time Savings with Trastuzumab Subcutaneous (SC) Injection vs. Trastuzumab Intravenous (IV) Infusion: a Time and Motion Study in 3 Russian Centers
Time and Motion (T&M) studies are observational non-interventional studies to quantify efficiency-related outcomes.In Russia, trastuzumab (Herceptin®) is approved, among other indications, for the treatment of patients with HER2-positive Early Breast Cancer (EBC). A new...
Implementation of International Chart Review Studies: An Assessment of Ethics and Regulatory Considerations
In the absence of suitable secondary sources of healthcare data, chart review studies offer an effective method to capture and analyze real-world data on patient demographics, clinical characteristics and outcomes, treatment patterns, treatment effectiveness, and safety. For...
In absence of patient-level databases, multi-national, retrospective chart review studies can be undertaken to provide robust naturalistic data to inform evaluations of treatment patterns, resource utilization, costs of care, clinical outcomes and safety.
In the EU, new medications must be scrutinised by the EMA's centralised application review process before gaining approval – so accompanying safety and regulatory documentation must be properly prepared and consistent to ensure it passes the test.
Providing precise data capture and management as well as comprehensive statistical analysis of all phases of clinical research, REMS requirements, and outcomes and registries studies UBC’s Data Management and Biostatistics services bring together technology and therapeutic...
Retrospective chart review designed to fulfill real-world evidentiary requirements
At UBC, we use the latest technology and employ experienced and dedicated people to deliver global patient recruitment offerings.
UBC’s experience in strategic clinical development and execution of both registrational and peri-approval studies spans four decades, across most therapeutic areas, and around the world. UBC’s clinical teams collaborate with sponsors to help ensure conclusive study results and...
Maximise product performance by managing risk before, during, and after launch with the industry’s most comprehensive and global suite of solutions available.
UBC provides technology and services that encompass safety/pharmacovigilance, risk management, signal detection, and assessment – as a comprehensive integrated programme, or as stand-alone, targeted solutions.
Achieve and maintain market authorisation in Europe. UBC offers customised consulting, development and implementation solutions.
While some procedures and guidelines exist for company sponsored web sites, the strength of the pharmacovigilance data getting available from the non-sponsored sites is growing and hence there is a growing need to develop strong and much clearer guidelines to monitor the...
All Marketing Authorisation Holders are required by regulation to demonstrate a systematic and documented approach to signal management, the output of which should be appropriately reflected in the benefit-risk assessment of the product. The signal management process can be...
The objective of this abstract is to describe new evidence requirement challenges imposed by regulators with respect to evaluations of drug safety post-market and discuss logistical challenges and timeline constraints associated with chart review DUS to inform dialogue and...
A targeted search was conducted in MEDLINE to identify all original research published in 2013 reporting results from registries. The search was restricted to English language publications. Abstracts of relevant citations were reviewed to obtain the country of study, therapeutic...
The convergence of payer and regulator evidence requirements warrants a strategic evidence generation plan and a mindful orchestration of peri and postapproval real-world studies. Study designs resulting in a diverse array of health economic and safety data are increasingly...
Krista Payne and Dara Stein discuss the use of retrospective chart review studies as a way of capturing real-world patient-level clinical, healthcare and safety data. PharmaPhorum, December 2013
The strategic uncertainty confronting big Pharma today has put a premium on generating new ideas from outside sources – it’s the fresh wind that lifts the sails. CROs and other biopharma vendors with a business mission to guide the industry through an era of rapid change are...
Risk management plans and risk minimization plans as well as postapproval commitment studies are based on risks identified pre-approval that need to be further characterized or minimized in the postmarketing environment. Although the implementation of these activities are...
Increasingly, to meet marketing authorization and risk management real-world data needs, regulators are requiring real world prescription pattern data including off-label information. In the absence of suitable databases, chart review studies can result in robust datasets...
In multi-centre Time and Motion (T&M) studies, time endpoints can be highly variable due to differences in centre practices. Our aim was to assess the impact of the type of analysis employed on the results of a T&M study.
A major challenge for haemodialysis (HD) centres is to maximise efficiency in care provision while maintaining high standards of care. Our objective was to document health care professional (HCP) time for renal anaemia management for both shorter-acting erythropoiesis-...
To describe existing models of pharmaceutical care (PC) in England, Poland, Germany, Denmark, Italy and United States and to indicate similarities and specific attributes meant as differences (from the whole system point of view), identifying possibly promising solutions (...
To review design characteristics of T&M studies applied to healthcare, with a focus on choice of study design, statistical methodology, and handling of multi-centre data.
To elicit utility values from EQ-5D for patients with various stages of mCRC.
There is an increased need to conduct international chart review studies (chart reviews) since healthcare databases with required information are not consistently available. Chart reviews offer an alternative for the effective capture and analysis of real-world patient-level...
From September to December 2010, a recall of peritoneal dialysis (PD) solutions (1 Dianeal and 2 Nutrineal lots) was initiated in Europe. These 3 recalled lots (manufactured at 1 site in Ireland) were related to elevated endotoxin levels and associated with increased sterile...
Increasingly, to meet marketing authorization and risk management data needs, regulators are requiring real world prescription pattern data including empirical off label-use. In the absence of suitable databases, chart review studies can result in robust datasets appropriate for...
In the absence of suitable healthcare databases, chart review studies can result in tailored datasets suitable for evaluations of burden of illness, unmet need and drug utilization and safety. This methodology, however, is associated with significant design and operational...