Data Management & Biostatistics
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Consulting
A Primer on Cancer Immunotherapy
In recent years, immunotherapy has led to substantial advances in cancer therapy. In particular, the immune checkpoint inhibitors — PD-1/PD-L1 and CTLA-4 inhibitors — have revolutionized treatment for certain hematologic malignancies and solid tumors. To date, the U.S. Food and Drug Administration (FDA) has approved immunotherapies for more than 15 cancer indications. However, widespread use...
Clinical Research: Phase 1 - Phase 4
Leadership Development and Becoming a More Effective Change-maker
They say that great leaders aren’t born, but grow into their positions through sweat and tears. No matter what stage in life, industry, or phase of your career you’re at, it is important to continuously strengthen your skills, and this ongoing development is one of the key values we look to foster in our team...
Medical and Regulatory Affairs
Brexit is Pressuring Sponsors. Here’s How We’re Responding.
Months before Britons voted narrowly to leave the European Union (EU) in June 2016, then-U.K. Prime Minister David Cameron called a vote to withdraw from “the gamble of the century” and warned of dire political and economic repercussions. More than two-and-a-half years later, Cameron’s warning sounds more prescient than ever. Countless unanswered questions confront British...
Medical and Regulatory Affairs
Developing Best Practices for Forging Strategic Sponsor-CRO Partnerships
Dr. Krista Armstrong, Vice President, Neuro Business Unit and Strategic Development, discusses best practices for forging strategic Sponsor-CRO partnerships. As recorded at OCT New England.
Clinical Research: Phase 1 - Phase 4
Understanding Recent Updates to the Classification of Rosacea
Since 2002, doctors and researchers have used a standard rosacea classification system to provide consistent terminology as well as to facilitate studies, clinical diagnosis, and treatment. However, in 2018, the Journal of the American Academy of Dermatology published a new standard classification system that replaces the previous one[1]. Below is some of the most important...
Consulting
Current Rosacea Treatment Algorithms: Guide to Subtypes and Existing Therapies
Rosacea is a common condition occurring on the convexities of the face and affecting middle-aged persons. It may be caused or worsened by a variety of different factors, including genetics; problems with the blood vessels in the face, the nervous system, and/or the immune system; the presence of Demodex mites; and environmental factors. It is...
Clinical Research: Phase 1 - Phase 4
The Placebo Problem in Pain Research: Keeping Up With the ‘Mrs. Joneses’
We were conducting a trial for a painful diabetic neuropathy (PDN) drug and were investigating why one site had an especially high placebo response rate. Then one of our representatives, waiting in the site’s lobby to meet with the principal investigator, pinpointed the likely reason when a patient walked in the door. “Mrs. Jones,” the...
Consulting
A Strategic Partner, or a Vendor Looking to You for the Answers?
Your compound holds great promise, and your investors are banking on a breakthrough. Which do you pick to run your clinical trial — a CRO that will share the risks and work with you to reach a common goal or a vendor who’s waiting on you to have all the answers? Any capable CRO can provide...
Consulting
Nostalgia or Shell Shock? Assessing PTSD Is a Challenge by Any Name
Nostalgia. Irritable heart. Shell shock. No, this isn’t a word-association game. These are among the many terms applied over the years to the highly amorphous condition we now call post-traumatic stress disorder. While people have experienced shocking, scary, and dangerous events since the dawn of mankind, the study of the cause and treatment of PTSD...