|
|
|
| home > ict > Spring 2010 |
|
|
 PUBLICATIONS |
International Clinical Trials |
|
|
|
|
|
 |
| |
|
|
|
|
| Walter Janssens, Kristof Bonnarens and Greet Musch at the Federal Agency for Medicinal and Health Products, Belgium, outline the regulatory rules for exploratory clinical trials. |
|
|
|
|
Mario Tanguay of Anapharm looks at new strategies for designing and conducting Phase I studies which can help to streamline the early clinical drug development process. |
|
|
| Having already been recognised and applauded for their achievements to date,Vanessa Poustie gives us an insight into what else to expect from the NIHR Medicines for Children Research Network as they work towards improving child health. |
|
|
| Planning for a clinical study is more than just determining the aim, as John Shillingford at Averion will tell you; in these times of financial crisis, the metrics – costs and timelines – of a study are just as crucial. |
|
|
| Scientists are probably not always best known for their communication skills, concealing inadvertently the very thing they mean to communicate. Julia Forjanic Klapproth and Barry Drees of Trilogy Writing & Consulting GmbH examine the role of the medical writer as a strategic partner on the clinical team. |
|
|
|
|
| Karen Politis Virk at Language Connections looks at the benefits of outsourcing clinical trial research to South Korea over other emerging markets, as well as the challenges faced by investigators. |
|
|
| If you’re thinking of conducting clinical trials in the Middle East and North Africa, Maha Al-Farhan of ClinArt International provides accurate up-to-date information about the laws and regulations in the region. |
|
|
|
|
| As the functional service provider (FSP) model increasingly replaces the traditional CRO paradigm for data management, Nelson Lee at the Society for Clinical Data Management reveals the elements needed for a successful FSP partnership. |
|
|
| John F Tomera at WorldCare Clinical illustrates how adaptive clinical trials may be the future of R&D – citing adaptive designs, interim analysis and imaging CROs as tools for ensuring more effective portfolio management. |
|
|
| Paula McHale at Perceptive Informatics explains why, despite the availability of electronic data capture technology, paper can be the best way to go on occasions. She provides guidelines for selecting a good hybrid tool that can manage both means of data collection. |
|
|
| With the recent financial pressures on the pharmaceutical clinical development process, Ed Krasovec of STARLIMS Corporation explores the use of Laboratory Information Management Systems as a solution to the problem – improving efficiency and reducing costs. |
|
|
|
|
| Intranasal drug delivery has always been a viable alternative to oral or subcutaneous routes for drugs with low bioavailability and, despite the challenges involved, recent developments have been eye-catching, explains Andrew Leary at Shandon Clinic. |
|
|
|
|
|
 |
|
|
 |
News and Press Releases |
 |
Clinical and Regulatory Operational Excellence Forum
1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment?
Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
More info >> |
|
 |
White Papers |
 |
|
Finding the Right End-to-End Safety Solution for Your Needs
Bioclinica
With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
More info >> |
|
 |
Industry Events |
 |
INTERPHEX 2019
2-4 April 2019, Javits Center, New York
At INTERPHEX, find all of the State-of-the-Art Solutions you need to
Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier
pharmaceutical, biotechnology, and medical device development and manufacturing
event and sponsored by Parenteral Drug Association (PDA). Dedicated to
Innovation, Technologies and Knowledge, the show focuses on the entire product
development life cycle.
More info >> |
|
|
