Issue Focus

Webcast/Podcast Topic

Deadlines

April

Getting to the Root of Pharma's Public Perception Problem: The pharmaceutical industry ranks right behind tobacco companies on public trust. The increasing focus of both Congress and the public on this industry is of concern to many within the industry. What can be done to change the public face of pharma?

Feb. 15

May

Biotech & Clinical Process
In this dynamic and growing part of drug development, this issue will address the specific needs of clinical trials in biotechnology.

Imaging Biomarkers: A Bump Up for Trials: The market for imaging biomarkers is beginning to realize full potential. With the convergence of FDA acceptance, the need to prove drug safety and efficacy earlier in the drug development process; and the development of the technologies and processes necessary to support better data in clinical trials, the future for imaging biomarkers is here now.

Mar. 15

June

Industry Outsourcing
Outsourcing in the clinical trials industry remains the most competitive way to get drugs to market. What outsourcing paradigms work best and how to effectively manage the outsourcing relationship.

Mumbai: A Place to do Business: How will the recent terrorist activity in Mumbai affect the clinical trials industry in India? As the clinical trials market has grown in India, and continues to grow to an anticipated $500 to $600 million by 2010, what can be done to minimize concerns regarding India as a place to conduct trials?

Combination Drugs and Devices: A look into this growing market. FDA regulations; using outsourcers and vendors in achieving approvals; best practices.

Apr. 15

July

The Investigative Site Investigative sites remain the place where patients and clinical trials meet. How has the site changed over the years, what are sites doing differently in the changing industry and what strategies can be employed to make site conduct more effective?

The Worldwide Patient: How patient/subject recruitment differs in each country in the world. Considerations, challenges and benefits.

May 15

August

EDC & eClinical Trials
An update on how Electronic Data Capture (EDC) and Electronic Clinical (eClinical) tools impact the clinical trials industry.

EDC: Real-World Case Studies:
Useful information on the actual implementations, challenges, and benefits from an EDC software system.

June 15

September

Regulatory Update
Regulatory issues are the backbone of the clinical trials industry. This issue looks at recent regulatory changes that impact the industry.

n/a

July 15

October

IT & eClinical Approaches Information technology improves the way clinical trials are conducted through efficiency and time savings. A look at the latest developments in IT and what to consider in new IT implementations.

ePRO Update: What's new in electronic patient reported outcomes.

Simulation, Modeling and Forecasting Software: How the use of simulation and forecasting software in different areas of the clinical trials paradigm are changing the way business is conducted.

Aug. 15

November

3rd Annual Salary Survey
With the rapid developments in the clinical trials industry, the roles and careers of professionals are constantly changing and evolving. This issue examines these changes and offers advice on personal development.

New Skill Sets for Project Managers: The role of the project manager is changing along with the industry. More emphasis on global trials; more use of data collection, simulation and modeling; and increasingly complex protocols all equal a change in skills for the project manager.

Sept. 15

December

15th Annual Resource Guide and Corporate Profile Issue
Bound into the December Issue A yearly update of corporate profiles, directories, glossaries, associations and societies, and Internet resources, quality assurance; analytical method development and validation, statistical methods, GMPs, validation, regulatory compliance.

n/a

Oct. 15