Clinical Trials
Managing a Major eCTD Filing
An Amgen case study
The electronic Common Technical Document eCTD format provides an opportunity for regulatory operations groups to gain significant efficiencies through the standardisation and automation of publishing processes In order to take advantage of this opportunity it is important to first identify what kinds of tools are needed Some of these tools are elem...
Clinical and Non-Clinical Investigations
Improving the quality of development candidates
The pharmaceutical industry continues to face challenges in improving its RD costeffectiveness Despite the steady increase in the RD expenditure in the US pharma industry over the past years from US billion to US billion the number of new products launched has decreased from in to in Price Waterhouse Coopers Pharma There is not a s
Site Management Organisations in Asian Clinical Trials
Providing Competitive Advantage
Site Management Organisations SMOs frequently act as both partners and competitors in the conduct of clinical trials for Contract Research Organisations CROs and claim to show advantages over them to pharmaceutical companies Most effective is the integration of study site management in the classical CRO clinical services as it eases the communicati...
Foreign Biotech Trials In Asia
Emerging Trends
It has been suggested that the biotech sector in the Asia Pacific region is rapidly growing and could become a serious competitor to the US biotech industry However regulatory hurdles lack of intellectual property protection as well as cultural factors could slow down the sectors development In this rapidly globalising world drug companies wishi...
Clinical Trial Integration
Adopting an Innovative Approach
The number of solutions available to automate the clinical trials process is increasing at a fast pace with each solution providing a variety of targeted benefits to suit different requirements Often the same data point is imported into and processed by these different solutions affecting specific aspects of the clinical trials process in a similar...
Growth in Japanese Clinical Trials Market
The clinical trials environment in Japan has changed dramatically over the last eight years In particular changes in the Pharmaceutical Affairs Law PAL have allowed the acceptance of foreign clinical data and fuelled the growth of the clinical trial sector in the country There is an increased need for businesses involved in clinical trials to take...
Decision Making in Drug Development
Innovative designs
Early clinical drug development is targeted at gathering information about the toxicity and efficacy of a new drug compound Phase I trials determine the maximum tolerated dose of a drug while Phase II trials explore efficacy and lead to a critical decision of gonogo in terms of continuing a drugs clinical program Bayesian designs are particularly s...
Clinical Outsourcing in Japan
Ready to fulfill its Destiny?
Japan remains the second largest national market for pharmaceuticals at of the global marketas defined by IMS And yet there remain varying opinions about the status of Japans pharmaceutical industry Japans unique regulatory requirements are often cited as a particular cause of frustration by multinationals However the Japanese government has taken...
Ethics in Clinical Trials and Drug Development
Ready to fulfill its Destiny?
Ethical considerations have been part of the conduct of studies with humans for several decades However it is only since WW II and several abusive trial situations coming to attention that ethical considerations have become a prominent and critical part of the conduct of clinical trials both for safety and wellbeing of the subjects or volunteers en...
Metabolomics Strategy
Identifying tissue-specific drug effects
Clinicians commonly rely on a tiny fraction of the information contained in the metabolome measuring eg glucose and cholesterol to monitor diabetes and cardiovascular health respectively New analytical platforms for metabolomics and tools for informatics that afford extended and sensitive measurement of the metabolome are therefore expected to beco...
