India’s CDSCO wants tighter rules for clinical trial imports

PharmaTimes reports that India’s Central Drugs Standard Control Organisation (CDSCO) wants to tighten up conditions for the import of larger quantities of drugs for use in clinical trials.

Write Peter Mansell reports that, the CDSCO has issued a proposed guideline that calls for additional documentation and evidence when contract research organisations (CROs) or other companies/institutions apply to import “appreciably large” volumes of drugs.

The regulations do not specify what “small quantities” are, and recently there have been a number of cases of manufacturers, CROs and other importers “submitting applications for the import of reasonably large quantities of active pharmaceutical ingredients and/or drug formulations which do not comply with the provisions of Rule 33”, , the CDSCO notes.

According to the CDSCO, the rationale behind the guideline is to facilitate drug R&D/contract research and to “boost the scientific and technological activities in this knowledge-based industry”.

India’s CDSCO wants tighter rules for clinical trial imports

Insourcing Is The New Outsourcing In Biopharma

Stephanie Wells of Life Science Leader writes, The growth of insourcing means that the future of contracted work is likely to be a blended approach. In some cases, the CRO would provide traditional external services, like general toxicology studies or Phase II clinical studies. In other cases, when a client is working in a new area and has not yet developed the necessary infrastructure, partnership with a broadly capable CRO means that many necessary services in the new field can be performed on an insourcing basis, including the help of an insourced “navigator” group of ex-FDA personnel who can guide the new compound through studies that ensure it has the best chance of proceeding efficiently through the regulatory process.

What do you think of insourcing? It is the new standard?

Insourcing Is The New Outsourcing In Biopharma

Software offers holistic insight into clinical trials.

Thomasnet.com reports that TrackWise Clinical Quality Management Solution provides end-to-end system that streamlines oversight of business-critical clinical trial processes while helping to ensure compliance with global regulatory standards. Driving organizational efficiencies from pre-clinical activities through manufacturing and post-market operations, solution delivers closed-loop process support to allow issues to be reconciled and corrected before they escalate.

Sparta Systems Unveils TrackWise® Clinical Quality Management Solution

Chinese CROs trial express customs clearance

PharmaTimes reports that, three contract research organizations (CROs) operating out of China’s Zhangjiang Hi-Tech Park are trying out a new express customs clearance model that could eventually be extended to other CROs in the Park. Its been well-known that customs clearance for CROs has been a difficult process for many CROs, with the new customs clearance model high import/export volume and strict storage requirements could be alleviated.

What other processes can help CROs allevaite tight customs clearance requirements?


Chinese CROs trial express customs clearance

CROs 2009 Workshop Video

For those who missed the workshop last month in Orlando, we are providing unlimited access to this timely workshop to all Partnerships attendees and their colleagues. And since we understand your training and travel budgets are limited at this time, this video workshop is completely free of charge.

Simply click the link below to watch the video at your leisure, and feel free to pass along to your CRO colleagues.

www.iirusa.com/cropartners/BDWorkshop.xml

If you are in business/corporate development, sales, marketing, client relations, account management, operations or project management at a CRO or other outsourcing provider, this video workshop will help you achieve your professional development goals including:

• Demonstrate value to Sponsors who are increasingly pushed to make decisions based solely on cost
• Understand how downsizing in pharma will make micro-managing a thing of the past as CROs take over as the ‘doer’
• Access the right people (decision makers) in an organization to approach for new business opportunities -- and getting them to return your call
• And much more....

As Sponsors increasingly look to CROs to provide expertise, what level of experience do CRO project managers need going forward?

Partnerships with CROs is providing unlimited, complimentary access to the video of our highly rated premier workshop for CRO Business Development professionals, CRO Strategies for Adapting to the Changing Tides in Pharma.

This in-depth workshop provides CRO BD Execs with the strategies necessary to approach, interact and work effectively with your current and prospective biopharma clients. And it's all FREE! Tell a friend:

http://www.iirusa.com/cropartners/BDWorkshop.xml

CROs in disguise

Brian Orelli at The Motley Fool writes on the basics of CROs, or CROs 101 for the non-industry professional. Orelli outlines a few characteristics of CROs but what was most interesting was his claim that some CROs can be disguised and, according to Orelli, it seems (to me) that pharmaceutical companies are essentially turning into holding companies that license or purchase drug candidates, escort them through the regulatory maze, and produce and hock them once they get past the FDA. Which he claims isn't a bad business model. Check out his piece here and let us know your thoughts.

Revisiting Ethics of Global Outsourcing

On his blog, Global Bioethics, Stuart Rennie discusses a topic that we covered last week concerning unethical outsourcing practices. Rennie's take includes, "It is a charming idea that ethics committees would be responsible for stimulating the globalization of research (and indirectly, the ethical problems that go with it), but it seems more likely that streamlining the processes at home will simply increase the number of trials abroad, as long as the economic disparities between countries remain in place. You will simply get your IRB approval faster. Besides, if you want to 'de-incentivize' clinical trials abroad, why not build up ethical review in developing countries, or force pharmaceutical companies to pay to build local health infrastructure and capacity as a cost of doing business, rather than scaling down IRB processes at home?" We encourage you to post your comments here or on Mr. Rennie's blog.

Raising alarms, study sees trials migrating abroad

John Carroll at FierceBiotech.com reports that the U.S. drug industry has shifted most of its clinical trials to overseas sites in a trend that experts warn raises serious ethical concerns. According to a study in the New England Journal of Medicine, 13,521 of 24,206 trial sites being sponsored by the top 20 U.S. drug companies in late 2007 were taking place beyond our borders, where data can be harvested cheaper and faster than the data gathered inside the U.S. And the study adds that the number of countries hosting trials has doubled in 10 years. Most of the countries hosting clinical trials may be using individuals who could never afford the medications and approval for these trials has been less than half. What are your thoughts?

Drug CROs: Good Medicine for Investors

According to The Motley Fool, CROs are a solid investment for investors because they have experienced substantial growth because of increased research and development outsourcing by the biopharmaceutical industry. They outline specific CROs to watch in the coming years. What do you think? In a tough economic environment--are CROs solid for investment?