India Expected to Take Larger Share of Outsourcing Sector

According to this article in outsourcing-pharma.com the outsourcing sector in India is expected to grow at 43 percent due to the diminishing concerns of the about operations in that country. Predictions made by Ernst & Young show that India is still ranked highest among its outsourcing peers in cost efficiency. Also, the country's technological capabilities are far more advanced than many of the other competing countries. It will be interesting to see India will grow as expected, or if Eastern Europe or China will advance in the outsourcing sector.

Clinical Research Trials in India

Here's an interesting presentation I came across from Dr. Shreyashi Ganguly in the Curious Insanity blog. The slide-show get some of his points across on the fastest growing industry segment of outsourcing clinical trials. Take a couple of moments to view it below. Enjoy!

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?

Shifting Clinical Trial Environment

Earlier today, I came across this great interactive treemap in this post in outsourcing-pharma.com that presents a unique visual analysis of the globalization of clinical trials and rise in CROs in the past 20 years. Take a couple of minutes to view this informative map.

View the interactive map

The Use of Bid Grids for Selecting a CRO as a Partner

This article in Applied Clinical Trials details how most companies use bid grids in order to establish both an overall outsourcing budget and the expected budget for individual major outsourced studies. So who's using bid grids?

According to the article 90% of the American participants of a suvey conducted by the University of Health Sciences and TTC reported using a common bid grid, in contrast to just over half, 52% percent of locations worldwide. 81% of larger pharma companies reported using a common bid grid as opposed 49% of participants from smaller companies that use a common bid grid.

Do you think bid grids are useful?

Tips and Trends on Global Clinical Trials Outsourcing

I came across this great podcast from PharmaVoice on their blog where Patrick Durbin, VP of Fisher Clinical Services, offers some best practices for developing a strategic partnership with outsourcing providers, discusses some of the biggest challenges and missteps in global clinical trials outsourcing, covers emerging opportunities at the global level, and lists some of the most important emerging trends in this arena. Take a couple of moments to listen to the podcast.

Play the PharmaVoice Podcast

i3 Launches New Software to Manage Clinical Trials Activities

This article in Clinical Trials Today discusses how i3, a contract research organization, has launched a new web-based clinical trials and data management program that will replace the need for multiple systems to manage all of these activities.

i3 CEO Glenn Bilawsky mentions, “i3Cube was designed to provide our clients and clinical investigators with a simple, easy-to-use, and streamlined experience. We brought together our use of proprietary health care claims data with our clinical research expertise and developed i3Cube to create time and cost efficiencies for our customers.”

It will be interesting to see what other web-based applications will be released in the upcoming months to help improve efficiency in outsourced clinical trials.

Unethical Clinical Trial Outsourcing

This article on Outsource Portfolio details that the growing numbers of companies outsourcing to India is a good thing, so as long as it does not cut the need to protect patients’ rights.

To ensure that patients’ rights are protected overseas India has created an online registry for all trials being conducted in India. This registry allows data to be integrated with data from the World Health Organization further ensuring that all global standards are met. Will this truly help ensure the ethical conduct of clinical trials in India?

New regulations from the Indian government

BNet is reporting that the Indian government may soon impose new regulations on clinical research outsourcing to its country, as well as create a Central Drug Authority to monitor clinical trials that are outsourced by North American and European Countries. It would look to protect patients in CROs in regions such as India, China and Africa. For more, read the article here.

Is Outsourcing of Clinical Trials Faulty?

A recent article in the NY Times raises the question about the ethics of conducting clinical trials outside the US when these studies are meant to gather evidence for drug approval in the country.

The article which was written by several Duke University researchers and was published in the New England Journal of Medicine discusses how medication that is intended for the wealthy should not be tested on people in developing countries. The report questions whether or not testing drugs in developing countries is even relevant to American patients.

What are your thoughts?

Read the January Partnerships with CROs LinkedIn Roundup

Here’s your chance to view our monthly newsletter that we send out to our Partnerships with CROs LinkedIn group with the latest updates in outsourcing and clinical development. Remember, to join our Partnerships with CROs LinkedIn group and update your email addresses on LinkedIn in order to receive it on an ongoing basis. Enjoy!

http://www.iirusa.com/upload/wysiwyg/CROs_January_Newsletter.html

India Expected to Draw More Clinical Trials by 2012

Even though there are several reports indicating the trend of outsourcing clinical trails to India, trials conducted in India only represent two percent of the worldwide total according to this article in Fierce Biotech.

The research group RNCOS also expects the number to surge to 5 percent by 2012 as more companies look to conduct low-cost trials in India. According to RNCO,

"companies can cut up to 30 to 40 percent time required to complete various phases of clinical trials choosing India as the outsourcing destination."

Take a look at RNCO’s full release here.

Ethical Guidelines in India

I came across this presentation from Ubio on slideshare that outlines general ethical guidelines to be followed when conducting clinical trials, especially overseas. Take a couple of moments to review it.

Ethical Guidelines for Clinical Research - India and the World

View SlideShare presentation or Upload your own. (tags: research clinical)

CRO PharmaNet Development Group Explores Strategic Alternatives

ClinicalTrialsToday reports that PharmaNet Development Group, which is a troubled CRO, is working alongside UBS to explore alternatives, including the potential sale of the company.

The company’s share price has plunged from $39.19 in January to $1.01 in early morning trading Friday. The company has also received some letters of interest regarding the sale, but PharmaNet will not comment any further until a decision is made.

Keep Clinical Trial Participants in the Loop

This article on Outsourcing-pharma.com explains how not informing clinical trials participants of the study results may leave them confused and frustrated, and lacking information that might be important for their health. Currently, clinical researchers are not required to tell participants the results of the study, but they are required to tell them information that might affect their willingness to participate in the study.

When a group of people were informed of the research results via a site call, roughly 90 per cent of participants reported “high or complete satisfaction”, and when they informed of the results through the sponsor’s press release only 50 percent reported “high or complete satisfaction.”

Child Death Rate in Outsourced Clinical Trials in India

This post on InjuryBoard.com highlights how 49 children involved in clinical trials in India have died since 2006. Dr. Vinod K. Paul, the head of pediatrics the All India Institute of Medical Sciences, mentions that all these children have died from serious illnesses and not the nature of the clinical drug trials itself.

Still there is some concern that many illiterate, poor families who do not speak English sign contracts written by foreign lawyers without understanding the nature of the clinical drug trials. Other hazardous problems include the lack of inspections at the factories and fraudulent clinical trial data.

Most companies are turning to foreign countries because of fewer restrictions, and where patients don’t fully understand but sign consenting documents anyway. What are your thoughts?

Tigermed Consulting Announces OCT as a Partner in Russia

PMR reports that Tigermed Consulting, a Chinese CRO, has formed a strategic alliance with OCT, which is a Russian based CRO based in St. Petersburg. Tigermed is trying to create a global clinical trials network with this move. Read the full article here.

Bilcare Boosts its Clinical Trial Business in India

This article on outsourcing-pharma.com reports that Bilcare has extended its clinical trials business with the opening of new packaging and storage capacity at its facilities in Pune, India.

Ajit Dubhashi, president of Bilcare GCS, Asia Pacific mentions:

"This will significantly enhance the capability of sponsors to conduct clinical trials across the world - inclusive of Asia- with desired alacrity.”

This deal has enhanced their global reach in Argentina, Brazil, Columbia, Chile, Mexico, Peru, Russia and Eastern Europe.

Regulatory Changes in India

Bio-IT World reports that in an attempt to broaden examination of the clinical research process within its borders, “India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS).”

The Indian Council of Medical Research has been regularly working towards establishment of a mandatory clinical trials registry to improve the reliability of data. The growth in clinical research in India continues, and so the importance of clinical monitors and research associates increases. India will have to play close mind to regulations over the next years since CRO growth is expected to increase in rapid numbers.

Clinical Trial Regulations Grow Tighter Overseas

John Carroll explains in this post on FieceBiotech that lately overseas regulators have been tightening their grasp of clinical trials around the world. Polish investigators want to know why two seniors died when they took two experimental bird flu vaccines developed by Novartis, and this is just one case of the tight regulations being put in place.

There is a growing concern that in the developing countries, the citizens are being used to test new drugs which will later be sold to more affluent markets. The Wall Street Journal estimates that roughly 40 percent of all clinical trials take place in lower-income countries.

Read the entire article in the Wall Street Journal