Electronic Integration Costs

Some of the most important issues facing our industry today center on the true role of electronic data capture (EDC). Should it be considered part of electronic health records (EHR)? Who owns the integration of IT data management across clinical trials and patient records in clinical science—and how should the costs be covered?

These were only a few of the questions that arose following a survey conducted by the eClinical Forum last year measuring the global use of EDC in clinical trials—a follow-up to a similar survey conducted in 2001. Of course the world is a bit flatter now than it was then, and the facilitators expected that the data would reflect some significant changes in the industry. Read More »

Posted in IT | Tagged , , , , , , | Leave a comment

Career Development: Cold Calling, Networking, and More

I recently spoke to two recruiters for the clinical trials industry about job searching and career advancement. Here’s what they had to say about networking, and how to go about searching for a job in the first place:

Besides searching for opportunities online and on company websites, what are some other ways a candidate can go about a job search? Would you recommend cold calling a company or even stopping by in person?

Angela Lucas, Senior Clinical Team Lead and Recruiter at ClinForce

  • Candidates should create a network to keep in tune with new employment opportunities.
  • I suggest working with no more than three recruiters with whom you develop a strong relationship.  Keep track of where your resume is sent and by whom.
  • Sign up on job boards that offer e-mail alerts based on your interests to keep you updated on available positions.
  • Networking with colleagues: Some groups or even individuals create their own e-mail alert list to share new openings with one another.
  • Join associations. Many professional associations’ post-employment opportunities for their members at national and local levels including websites, job fairs, trade shows, etc.
  • Cold calling; though not unheard-of, it is a bit difficult.  Unless you are confident you can get past the gate keeper, I would refrain.
  • I would not suggest stopping by in person. Many offices are not set up to accept walk-ins and usually, you are referred to look at their online postings.

Angela Roberts, Head of Recruiting Operations at craresources

  • First, use industry specific information to find out what is actively going on and approach teams directly. For example, in our industry you are able to visit clinicaltrials.gov and see what trials are currently running in your favorite therapeutic area. Those trial listings will have contacts (CRCs, PIs, etc.) and there is nothing wrong with contacting those individuals directly! I would recommend sending a well-tailored e-mail with a copy of your resume. Then follow up with a rehearsed and professional phone call/voicemail. Be sure to clearly articulate why this trial is perfect for you—you will need your passion and excitement to leap off of the e-mail and be clear in your voicemail.
  • Second, use your network! Don’t underestimate who you know. We have written an article which goes into detail on how to build, nurture, and leverage your network when looking for a position.

Posted in Uncategorized | Tagged , , , , , , , , , , | Leave a comment

Supreme Court to Consider Sales Rep Overtime

Posted in Uncategorized | Tagged , , , | Leave a comment

New Industry Models: The Blurring Lines Between Drug Safety, Regulation, and Access

I begin this article exactly where I left off in my previous one–a quotation that “99% of future predictions will fall short of the necessary unreasonableness for a correct prediction,” for I wish to discuss another subtle trend that appears ever more plausible each passing year. When drug regulation began, its mission was to assure efficacy and quality, whereas food regulation primarily focused on safety. In time and as we learnt about adverse events, regulation became about all three, and establishing enough data to achieve approval and access. After decades of this regulatory model in balance, many long held precepts have evolved significantly over the past decade.

Safety has emerged as perhaps the core beacon guiding regulatory action and oversight today. It is well accepted that approval is in fact based on “a point in time” and our knowledge evolves over a lifetime–leading to expanded or restricted indications. A clear fourth hurdle has emerged as the true arbiter of access–reimbursement—based not only on regulatory approval (absolute effectiveness) but on principles of “value,” comparative (cost) benefit profile that includes both efficacy and safety. What appeared unreasonable only a few years ago, regulatory approval itself rooted in comparative benefit, now appears plausible. In other words, the lines between safety, regulation and access are progressively getting blurred. Read More »

Posted in Regulatory | Tagged , , , , , , | Leave a comment

Signal Prioritization

In last month’s blog post we discussed the necessity and ability of systems to identify potential safety signals in our clinical, post-marketing, and surveillance data. This act of identifying signals in different sources2 is only the beginning. This month’s blog post will look at the various methods of signal prioritization that exist to assist us in the often daunting task of sifting through the identified signals so that we ensure proper distribution of resources. Read More »

Posted in IT | Tagged , , | Leave a comment

No Free Lunches for AIDS Research in Europe

Clinical research is playing a prominent part in the European Union’s response to HIV/AIDS in its member states and in neighbouring countries in eastern Europe, according to a review by the European Center for Disease Prevention and Control.

Some of the ongoing work funded by the EU is listed in an interim “special report” entitled “Monitoring implementation of the European Commission Communication and Action Plan for combating HIV/AIDS in the European Union and neighbouring countries, 2009–2013.” Read More »

Posted in Regulatory | Tagged , , , , , , , , , , | Leave a comment

Impact of Affordable Care Act on Pharmaceutical Industry

Posted in Regulatory | Leave a comment

Prescription Drug Spending Up In 2011

A report released by the IMS Institute for Healthcare Informatics revealed that per capita spending on prescription drugs grew by .5 percent in 2011. Read More »

Posted in CRO/Sponsor | Tagged , , , | Leave a comment

Modern Communications

The marketing environment today is difficult, whether your goal is to raise awareness for trials, increase direct to consumer sales or build a brand for new products. When faced with the challenge of outward communication for those messages, there are a lot of options.Chris Layfield
Read More »

Posted in CRO/Sponsor, Sites | Tagged , , , , | Leave a comment

Europe’s Top Regulator Shows His Teeth

Some business strategists believe that if you wish to radically overhaul an organization, then you must make your key changes within the first six months. When a new boss comes in, staff more readily accept new approaches, the argument goes.

Guido Rasi has now been executive director of the European Medicines Agency for nearly half a year, and one of the first indications of his most urgent priorities emerged on April 3 when EMA published its updated policy on conflicts of interests among the scientific experts and committee members it uses in its work. Read More »

Posted in Regulatory | Tagged , , , | 1 Comment