United Arab Emirates is Set to Rise in Clinical Trials

According to this post in outsourcing-pharma.com the United Arab Emirates is set to grow in the CRO industry due to the attractive of cost effectiveness there. Kermani, author of A quick guide to healthcare and biotechnology in the Middle East, predicts that with big pharma companies like Pfizer, Amgen and AstraZeneca establishing offices in UAE, many more CROs will follow.

What are some other companies that you have caught wind up that are trying to locate to UAE?

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

New online tool to help with compliance

Thompson Publishing has released a new online tool that will allow clinical trail conductors to keep up to date with key compliance issues and continue with their operations. CT Comply is a powerful database that provides up-to-the-minute news, analysis and research tools in one place online.

J.W. Schomisch, senior managing editor at Thompson, and editor of the widely acclaimed Guide to Good Clinical Practice, states:

"CT professionals have been asking for this for years. Now, with just a few quick clicks of a mouse, CT managers can find up-to-date advice to stay in full compliance plus powerful advice to help save time and money and smoothly speed their trials."

"The huge benefit of the online format is that we're able to keep the information continuously up-to-date. That way, clinical trial professionals will always have the latest news, analysis and practical guidance at their fingertips. We've made it all very intuitive and easy to use with several ways to find what you're looking for. "

Read more here.

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

How to find the best cost-effective treatments

According to Red Orbit, Congress has allotted $1.1 billion to begin finding the best treatments for certain ailments that are also cost-effective. A report came out addressing the top 100 medical issues addressed by Congress. The report said this of clinical trials:

“Clinical research provides health care providers with information on the natural history of disease, clinical presentations of disease, and diagnostic and treatment options,” according to the report.

“All too often, the information necessary to inform these medical decisions is incomplete or unavailable, resulting in more than half of the treatments delivered today without clear evidence of effectiveness.

“This uncertainty contributes to great variability in managing clinical problems, with costs and outcomes differing markedly across the country.”

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

Innovation needed for biotechs

An article in the San Francisco Chronicle believes that Biotech is in need of innovation, and points to diagnostics testing and biofuel production as the next possible chance, as it takes many many years to develop blockbuster drugs. Innovation was possible before because of the fact that investors were willing to risk time and money to come up with the next blockbuster drug. Innovation is critical in these few fields. What do you think? Where will innovation and production in teh biotech industry go next?

Clinical trial shows hope for no more insulin injections

According to The Medical News, an Australian clinical trial will commence for the treatment of type I diabetes that will not require daily insulin injections. The trial will now move on to Auckland, New Zealand in Middlemore Hospital.

Prof. Bob Elliott, Founder of LCT and diabetes specialist, said: "We have great hopes for these trials. We already have two patients in the Russian trials that are now off insulin and we are planning to use much higher doses of our product Diabecell in these trials."

Find out more here.

New software for clinical trials

TranSenda has a new software that will help the efficiency of all clinical trails. It'll improve the ability to manage the clinical study.

Cortex will enable organizations to leverage the power of access to centralized operational data from all applications used across all clinical studies.

Read more about the software here.

Finding patients in Phase I clinical trials

At FiercePharma, they look at how to effectively recruit patients in a CRO's local area for Phase I clinical trials. They suggest joining your local community to spread awareness and developing new media outlets to spread the word but not over saturate the market. For more, read the article here.

Sigma-Alpha Moves Differently from Classic CROs Offerings

Last week, Tony Fong of Genomeweb reported that, Sigma-Aldrich, hoping to grab a bigger slice of the biopharma industry's expanding appetite for outsourcing, (last) week expanded its services business to include mass spectrometry-based protein characterization, protein expression, and protein purification.

The idea is not for Sigma-Aldrich to collaborate with biopharmas on large-scale projects and manage them; "that's what a classic CRO does, and this is definitely not a classic CRO offering." Rather, what the company is offering is the chance for customers to choose individual services from a menu without fear of jeopardizing their intellectual property, she said.

In fact, the executive of one CRO said that because of the limited offering of services by Sigma-Aldrich, the two are not competing for the same business.

Sigma-Aldrich Debuts New Protein Services to Meet Biopharma's Growing Outsourcing Trend

Meetings Drive Business

This is why companies need to continue to invest in business meetings. Not only will those who attend gain new and fresh perspectives from other attendees, but they'll hear from top companies who have lived by the same philosophy. Investment in yourself and innovation are the key to your business. What have you done recently to invest in your business?

Did you get a chance to attend Partnerships with CROs this year? What would you expect to gain from the experience?

Meetings Drive Business

Merck to cut jobs

According to the New York Times, the Merck merger with Schering-Plough will eliminate 16,000 jobs from the company. After the merger, the group will be the second largest Pharma company. Pfizer will remain the largest. Read the full story here.

How do you pay the participants in your clinical trials?

In an article at ClinPage recently, they look at how Greenphire is speeding up the process of paying those involved in the clinical trial process. They believe that by making payments available through prepaid cards which are also electronic payments, a lot of confusion can be saved as well as those trial participants involved who are underbanked have a way to receive payments. Read the full article here.

Women in cancer clinical trials

According to a news article at the Atlanta Journal Constitution, clinical trials dealing with cancer research aren't including enough women. Doctors may not be able to identify all of the gender differences that occur between women and men, as only 37% of trial participants are women. Read the full article here.