In today's clinical trial landscape, a global footprint is instrumental in achieving full patient enrollment and on-time schedules. This White Paper includes 10 Tips for Feasibility Success and a Sample Feasibility Study Questionnaire.
This issue is an attempt to present the entire picture of the Russian market of clinical trials as of early 2007. It provides general information related to clinical trials in Russia, survey of the current legal basis, analysis of clinical trials being currently conducted in Russia by sponsors, phases and therapeutic fields, rating of the most active foreign and Russian drug developers, review of services and rating of contract research organizations available in Russia and investigative sites.
The growth in the number of clinical trials approved by the Russian Federal Agency for Health Care and Social Development (Roszdravnadzor) made up to nearly 40% in the 1st Quarter of 2007 as compared to the same quarter of the previous year. At the same time, the share of clinical studies initiated by Russian manufacturers has increased. The report comprises four tables and seven figures reflecting different aspects of the clinical trials market in Russia: balance between different phases and types of clinical trials, shares of foreign and Russian sponsors, ratings of the leading Russian and foreign pharmaceutical manufacturers, analysis of the leader's portfolio and many other facts of interest.
New methods for clinical trial costing and resource planning are rapidly gaining popularity. This paper compares one of these new methods, called Activity Based Costing (ABC) versus a traditional method of planning and budgeting for clinical trials. Pros and cons are discussed at the strategic level as well as the tactical/operational level to provide Executive Management and Director level clinical professionals with visibility to capabilities and limitations of both clinical costing methods.
When considering the purchase of a technology solution, many organizations mistakenly look only at the initial price tag of the software or hardware without considering all of the other factors that can affect the Total Cost of Ownership (TCO). These additional costs add up over time and can include customization, training and the overall costs to keep software up and running after the initial deployment. QUMAS developed this white paper to provide insight and guidance into the TCO process and its place in the overall solution sourcing and management process. Using this guidance and a calculator template included in the paper, you will be able to build an objective model that will assist you in differentiating and analyzing alternative solutions as well as addressing the "build vs. buy" dilemma.
The field of submission or dossier management has changed significantly in recent years. New electronic submission requirements, new technologies and varied agency implementation schedules for eCTD (electronic Common Technical Document) have added complexity and confusion to the submission management process. These factors have also changed the role of the submission manager and the skill sets required to be successful at submission management. This paper will discuss the changes that have occurred and how they impact the operational aspects of good submission management.
