Addressing the Challenges of Data Management for Pharmaceutical and Biotechnology Companies: Introducing Laboratory FSPx

The process of ensuring clinical trial records are accurate and fully reconciled between laboratory and clinical data sources can be a point of frustration for today’s pharmaceutical and biotechnology companies. Whether the data is coming from a contract research organization (CRO), a central laboratory or third-party laboratories, the need for timely availability of clean data based on unique sponsor format/industry requirements has become extremely complex.

“As the complexity of today’s studies grow, sponsors are often working with a greater number of laboratories in their studies,” explained Richard Cesarski, SVP, Patient Solutions, Safety and Data Sciences. “While these labs are specialists in sample management and generating results, their standard report formats may not be aligned to individual sponsor requirements.”

Recognizing this gap between sponsors, their clinical partners and the labs, Covance has launched Laboratory Data Management FSPx (Lab FSPx), a new solution within its Functional Service Provider (FSPx) offering.

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The Rewarding Career Path From a Study Technician to a Clinical Veterinarian

As a biology major, Tai had always planned on being a medical doctor, but when she reached her senior year in college she decided to explore other professions.

“My family had always told me, ‘you will be a doctor,’ and I didn’t think twice about it. But when I was finishing my undergraduate degree, I realized I wanted to figure out another way to make a difference with my career.”

After graduating, Tai explored positions in a variety of areas, including a volunteer position with the local humane society. At the shelter, she met another volunteer who was in a program to become a veterinary technician, and who encouraged her to learn more about the line of work.

“I enjoy working with animals, and a career in the veterinary field seemed like something that I could be excited about getting up for every morning,” Tai shared.

Starting a career with Covance, the drug development company of LabCorp

As she was completing her veterinary technology program, Tai needed to decide where, such as an animal hospital, research laboratory, animal shelter or private veterinary center, she wanted to work in the industry. Her program invited different guest speakers across the veterinary technology community to share their roles with the students.

“Hearing the guest speaker from a local research laboratory made me interested in learning more about the research side of the vet tech role. It seemed like a natural fit to work with animals and apply my scientific background from my undergraduate studies,” said Tai.

“When I became a licensed vet tech, a position for a study technician at Covance was available. I applied and was hired. Even though I had a 90-minute commute each way, I literally loved every single moment of the job.”

Recognizing the value of animal welfare

Although Tai had been inspired by the research technician who visited her vet tech program, she still wasn’t entirely sure what she would be doing as a study technician.

“I think the reason a lot of people don’t go into laboratory animal medicine is because they are not sure what it is about. I think people will find it’s much different than they expected,” said Tai. “When I started, I only had a vague idea about animal research and what it meant, but Covance provided me with a lot of on-the-job training.”

Tai also learned how study techs can help ensure that animal welfare remains a top priority.

“One day while we were running a study, a fellow study tech noticed an issue with a mouse. We called the veterinarian and he was there in less than five minutes to evaluate the mouse and make sure it got the care it needed. I saw first-hand how the animals were treated humanely and with respect, and valued the importance of my role as the voice for these animals.”

Growing her career and recognizing her impact on healthcare

Inspired by her work as a study tech, Tai decided to continue her education in the field. She left Covance and enrolled in a veterinary medicine program, earning her degree as a Doctor of Veterinary Medicine (DVM). During her studies, she and her husband adopted two red-footed tortoises after being a volunteer coordinator for the tortoises on campus. “We fell in love with the tortoises,” she laughed. “They have unique personalities, believe it or not.”

After completing both an internship and a residency program in laboratory animal medicine, she rejoined Covance, this time as a Clinical Veterinarian.

“I came back seven years later, and saw that some of the same people are still at Covance, including the veterinarian that had made such a positive impression on me,” she said. “I was so excited to be working with some of the same staff.”

Beyond working with familiar faces, Tai is motivated by her role in improving laboratory animal medicine.

“Good research comes from happy, healthy animals. I take pride in advocating for our animals and making a positive impact in their lives,” explained Tai. “Whether I am helping refine procedures to improve animal welfare, ensuring animals have the right enrichment in their environments, or simply changing cages, I enjoy the process of caring for our animals. Ultimately, I see how the care we provide for our animals results in valuable data that helps ground-breaking drugs come to life for both humans and animals alike.”

Learn more about our study tech opportunities here.

Minimizing Placebo Effect in Inflammatory Bowel Disease Clinical Studies

With 93 Crohn’s Disease (CD) and 168 Ulcerative Colitis (UC) Phase I-III industry-sponsored studies planned and open to enrollment, there is a significant focus on research into new therapies for inflammatory bowel disease (IBD)1.

Remission is the main aim of IBD therapy, but IBD studies often face challenges with minimizing the placebo effect2,3,4. Placebo effect can be categorized into placebo response/benefit (patients demonstrating an improvement) or placebo remission (patients achieving remission). Factors believed to impact the level of placebo effect can be contradictory depending upon whether a study’s focus is upon placebo response/benefit or placebo remission5.

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How to Renew Plant Protection Products – US Regulations

Important patent expiries are expected this year, and merger and acquisition activity among agrochemical companies is changing the competitive landscape. Against this backdrop, the history, knowledge and insight about established active substances could get ‘lost’, and such changes may pose risks for reauthorization of plant protection products (PPP). Find out here.

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