Design Your Dream Job Contest: What Should You Expect to Get from your Dream Job?

Common complaints of clinical job positions from GlassDoor.com are: “Lack of personal development opportunities," "lack of career progression within the company," "a lot of talk and no action," "under pay from market rate," and "no incentive to do better.” In addition, several former clinical employees working with CROs and clinical contract staffing companies have stated on Jobvent.com that they are "fed up with back-stabbing and incompetence,” an “unhealthy environment,” and high turnover.

“What Should You Expect?”

The best companies will provide the opportunity to grow your career, challenge yourself and allow you to provide insight and a point of view. The company as well as the job itself should offer a positive and challenging environment to help cultivate your skill set. Here is the top list of things that you should expect when you get a job.

Make a difference.
You should have the chance to make a difference in clinical research, helping bring drugs to market.

Have your ideas heard.
The company should allow you to showcase your expertise to further the Life Sciences field, creating new efficiencies and effectiveness in companies based on experience.

Become a Star.
While working at a company, they should have resources to get your name out there. You should have plenty of opportunities to effectively market yourself and your abilities to the Life Sciences industry

Be CHALLENGED.
Learn new skills and encounter new opportunities with their breadth and depth of available work experiences.

Be Part of a Community.
Beyond just exchanging information with each other, the company should have an elite team and consultant community that collaborates. Look for an extensive alumni program, superior benefits and a comprehensive loyalty program.

Pursue your Dreams.
Make sure you are truly happy at your workplace and can maintain an optimal work and life balance. Accommodating your personal preferences and career goals goes hand in hand.

Grow!
Understand your desired career path and ensure that you have job opportunities that help you build your skills in your desired direction. There should be sufficient intellectual capital that will help you get best practices experience every day.

These seven points were developed and are currently utilized by Advanced Clinical’s “AC Experience” framework for its consultants. We expect our consultants to work at the highest level possible, and we provide them with the opportunity and environment to do so.

So… “What's Your Dream Job?"

World-class Clinical Strategic Sourcing Organization (hybrid CRO and Clinical Contracting solutions), Advanced Clinical, wants you to “design your dream job,” and give us suggestions on how to provide the perfect work environment for clinical consultants. We will not only take requests to heart, but match you with a job as best as we can.

The best entry will win a $200 gift card to any store of his or her choosing, and two runners-up will each win an iPod shuffle.

You can enter by submitting a description of your dream job, a video, or any other creative form.

Design your dream job here.

Enter to win …August 17th is the new date we will choose a winner!

See www.advancedclinical.com

Advancing Discoveries: Regulatory and Risk Decisions in Adaptive Designs

Although adaptive designs produce numerous benefits for clinical trials, there are also a number of risks associated with it. Below, Advanced Clinical outlines some of the key risks when conducting adaptive designs as well as ways people mitigate them. Also are some FDA-accepted designs, including the more well known Bayesian approach.

What are the big, key risks?

One major concern is the effect of adaptive designs on statistical measures. Though addressed broadly, the issue of preservation of type I error rate remains a key issue in adaptive design. Also, changes in sample size, hypotheses, and other statistical measures affect the validity of the outcome data in clinical trials. Logistic concerns include methods on how to collect data. With interim decision making, data must be collected rapidly, and with short follow-up times in order for that data to remain relevant to the current state of the study. The main procedural issue to be followed closely relates to data review, careful decision making, and implementation of decisions during adaptive trials while maintaining trial integrity.

click picture for full view!

How do you mitigate those risks?

To mitigate risks that come with adaptive design, careful planning pre-clinical trial must take place. The right statistical measures must be in place and through simulation, the right statistical changes must be determined in case interim data suggests changes on statistical procedures. During clinical trials, it is recommended to have a Data Monitoring Committee (DMC) to review interim results and determine whether relative changes can be made. Also during trials, the use of clinical technologies such as EDC, IVRS and IWRS as well as light EDC are highly recommended in order to deal with the logistic concern of quick, responsive data analysis.

Some commonly accepted designs approved by the FDA (click picture for full view!)

Bayesian Adaptive Dose Allocation Approach (click picture for full view!)

See www.advancedclinical.com

Advancing Discoveries: Adaptive Designs in Clinical Trials

What is Adaptive?

In the past several decades there has been a recognized trend of increased spending within pharmaceutical, biopharmaceutical, medical device as well as biotechnology research without a proportional increase in success rate of clinical trials - there used to be 8 IDAs for 1 commercial success; now 16 INDs for 1 commercial success. Some of these could be due to diminishing improvement margins for new drugs, unchanging failure rates, escalating costs, and other clinical limitations. By advancing discoveries, Advanced Clinical seeks to determine the most efficient and effective way to conduct clinical trials without decreasing the safety or efficacy of the trial. Adaptive designs have recently become the frontrunner in advancing clinical trials. Adaptive designs are clinical study designs that utilize accumulating clinical data to modify the study as it progresses, without undermining the validity and integrity of the trial. Not all clinical trials are suited for adaptive design. Stay tuned for our next blog post on Adaptive Risk Management, and FDA accepted adaptive designs/regulatory perspectives!

Why do it?

Adaptive clinical designs save resources and increases efficiency of the clinical trial. Greater flexibility within the adaptive design framework can translate into better treatment of patients within trials (stopping ineffective/dangerous doses early), more efficient drug development, and better use of available resources (need for less patients). Adaptive designs are not only advantageous to drug development, but they are ethically beneficial to the patients. Trials can be cut earlier if they are ineffective, thus efficiently and effectively ensuring patients are well served with the appropriate dosages. This is most important not only because the clinical trial can save resources by cutting off ineffective arms, but the trial can also stop harmful treatments early on in order to prevent patient harm and preserve the overall safety of the clinical trial. Adaptive designs for clinical trials provide efficient tools to demonstrate the safety and effectiveness of new medical products in faster timeframes with more certainty, at lower costs, and with better information.

Types of Adaptive Design Options (click picture to view!)

With adaptive study design, there are many design options that affect different aspects of a trial. above are some of the more widely known adaptive options.

What are the Pros and Cons of Adaptive Design? (click picture to view!)

Adaptive designs, though having a lot of advantages, can have some disadvantages as well. Stay tuned for our next blog posting about the risks and regulatory perspectives surrounding adaptive designs.

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See www.advancedclinical.com