Outsourcing of clinical trials expected to rise by 25% by 2013 – is your team prepared?

With so much uncertainty surrounding the economy, consolidation of pharmaceutical companies, lack of funding for biotechs and drug safety concerns, one thing is for sure – there is still much work to be done to bring new medicines to market and we’re all being asked to do more with less. That’s why it’s imperative to get your clinical outsourced studies right the first time around. And, the long term view from industry experts is that outsourcing will continue to dominate.

But with so much flux in the marketplace due to career shifts, Big Pharma re-orgs and smaller pharma and biotechs ready to send new products into development, there’s a learning curve when it comes to making the right outsourcing decisions. You need to be armed with the information and contacts to get moving - the alternative can cause project delays costing into the millions.

Fundamentals of Clinical Outsourcing is a conference you can’t afford to miss!
→ If you are challenged by making decisions on full-service vs. functional outsourcing, or are struggling to convert a vendor bid into a study contract, you will benefit from the collective experience shared by our expert speaking faculty.

→ If change orders due to hurried or unrealistic scope of work or poor communication with your partners have just about stopped your trial in its tracks, you’ll find solutions for these challenges as well.

→ And, if you’re worried about quality oversight of third party clinical research data, you will hear directly from the FDA on what they expect.

Download the brochure for more information on how to do more with less and get your studies right the first time around.

We understand travel budgets are limited, so we are especially pleased to offer this program regionally in both Boston this October and San Francisco in November to facilitate your attendance.

Make sure to register before August 28th and Save up to $300! Mention Priority code 0T4JXO

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?

Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade

If you didn't have a chance to catch the web seminar "Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade" with Dr. Jann Neilson of Wyeth, please do! It was a very informative session.



Check it out here:

https://www1.gotomeeting.com/register/403770168



About the web seminar:

The Project Management Institute Pharmaceutical Specific Interest Group has sponsored 50-plus item surveys in 2001, 2002, 2005, and in the fourth quarter of 2008. There have been up to 711 respondents to each of the surveys. We have determined people’s profiles (e.g. what country they live in), the organization’s profile (e.g. large pharma, small pharma, biotech, CRO, consultant, etc.), and most of the questions were about project management in the person’s organization.



The seminar will describe the most interesting data from the 2008 survey and how it compares to previous surveys. For example, there will be a comparison of how project management occurs in large pharma, small pharma and biotech. Differences in how project management is performed in the US vs. EU vs. Canada will be shown. Comparisons between virtual and defined project management groups will be explored. Single vs. multiple function project management groups will be contrasted. These and other comparisons will be made in order to shown how project management in the life sciences is performed. As a bonus we will compare compensation and vacations in the US, EU and Canada.

Clinical Trials Market Expected to Grow in India Despite Economic Crisis

Outsourcing-pharma discusses in this post that even though the country is going through a rough economic crisis, the Indian clinical trial market is predicted to continue its growth. This information comes from a partner at Ernst & Young, and he also states that biotechs increasingly turning to India will help drive growth from its current $200m a year to $600m a year in 2010, which is what KPMG predicted.

Clinical Trials in an Emerging Brazilian Market

China and India have taken advantage of the need for outsourced clinical trials through contract research organizations, but a new study published by Frost & Sullivan shows that the Brazilian market is emerging as the future of clinical trials.

Daniela Putti, Industry Analyst at Frost & Sullivan mentions

“Higher costs, competition from generics, and lack of productivity from R&D have been challenging pharmaceutical companies worldwide to better manage R&D costs and deadlines as well as improve quality of the whole drug discovery process. To responsibly address these issues, pharmaceutical and biotech companies are seeking for more accessible and efficient clinical trial locations such as emerging countries like Brazil. Here these companies and Contract Research Organizations (CROs) may likely find promising market features and growth opportunities for clinical trials.”

How will this affect current outsourced clinical trials in other countries?

CRO Revenues are Expected to Increase

According to this article in in-PharmaTechnologist.com a recent study conducted by Turner Investment Partners reveals that while CROs are in demand across the whole pharma sector, they will be particularly important to smaller scale bio-pharmaceutical companies as they invest in new drug testing.

The article also details that 30% of CROs revenue come from biotech firms, which indicates that there will be heavy competition from the estimated 500 CROs around the world. Turner Investment Partners estimates that CROs will become part of up to 50% of all drug development projects at the clinical stage and pre-clinical stage within the next couple of years.

Proper Steps to Choosing the Correct CRO

In a recent article at Applied Clinical Trials, they took time to look in depth at the correct way to choose an clinical research outsourcer, and what steps should take place after the correct outsourcer is chosen.

The first step to starting a clinical trial is choosing the outsourcer. Gathering information to choose the outsourcer should be done in three steps. The planning phase happens with the biotech company chooses a CRO. There are two models of CROs a biotech company can choose from: one stop shop or full service (they complete every part of the process) functional outsourcing (establishing functions that the CRO can prepare). Protocol is also written during these stages. Next is the conduct phase. This is where the biotech company collaborates with the study sites and the trial sites have to attract the subjects. Should the conduct phase be operated by the CRO, it is necessary that they recruit the subjects in a timely manner and ensure that there are subjects throughout the trial. During the final evaluation phase, there should be a rapid evolution of study results, due to the processes that were planned an carried out in the conduct phase. Both the sponsor medic and the CRO’s medical writer should be in full cooperation in order to ensure a timely write-up and final report.

When it comes to the selection of the CRO, it is important to correlate the size of the CRO with the study you wish to perform. A smaller, new CRO will focus more attention on the project due to the success and recognition they will receive in the future, but a larger CRO will be able to handle larger test subjects and they could be more skilled to deal with the requests of the biotech companies.

As for the relationship with the CRO, the sponsor must maintain the relationship with the CRO and keep an open path of communication through out the process. It is beneficial for the sponsor to choose a CRO that has already developed a relationship with the investigators. It is also advisable to allow the CRO to work according to their own standards. The CRO must always be held accountable for the success of the study. With that said, it is also vital for the relationship between the biotech sponsor and the CRO to be a full partnership.

A structured communication plan should be documented, and each team should be accountable for upholding the plan throughout the clinical trial. There should also be a document that states the deliverables and the dates for the CRO. The CRO should also ensure that staff turnover does not interrupt the collection of data for the study.

The article concludes with this paragraph on finding success in the clinical study:

Outsourcing a clinical study by a biotech sponsor clearly demands a high level of professionalism and care when choosing the CRO partner. The success of the trial and the biotech–CRO relationship depend on a well thought out protocol and study conduct plan. These truths are more evident when the sponsor is a small biotech taking the large first step into clinical research. The importance of this decision must be reflected in management's commitment to allocate sufficient resources and provide ample support to the sponsor study management. Considerable efforts need to be taken to ensure that the trial is conducted using best practices to ensure its successful outcome.