July 2018 Newsletter
How Flynn LSG can help with potential CRO challenges
A CRO (Contract Research Organization) is a company that provides outsourced research services to the pharmaceutical, biotechnology, and medical device industries. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant.
In August 2013, the FDA released its guidance for monitoring clinical investigations.
According to the document, the FDA’s overarching goal is to “enhance human subject protection and the quality of clinical trial data by focusing Sponsor oversight on the most important aspects of study conduct and reporting.”
What does this mean? The FDA understands that contract research organizations (CROs) have had challenges on the quality of their deliverables to Sponsors throughout the trial duration and there are no guarantees on the quality of the work. This is not only disruptive to Sponsors, but to the FDA itself, the life sciences industry, and the patients who are made to wait for new treatments because of shoddy clinical trial work.
Flynn Life Sciences provides a solution to ensure an unparalleled quality of onsite monitoring throughout a clinical trial. Our team reports and remediates any clinical issues before they arise, working in collaboration with our Sponsor’s clinical operations teams. And, they close gaps throughout the process, optimizing outcomes as a trial moves closer to filing.
Trials that are delivered on-time and on-budget, and with the highest quality results/data … which further results in drug reviews that transcend human-error problems and receive approvals more quickly.
Recruiter Tip of the Month
Have a Results Focused Resume
In the past resumes were lists of duties. Today employers want to see results. They want to see the impact of your work and the benefits.
"Results" mean increased profits or cost savings. This can include increasing efficiency, decreasing waste, reducing risk, raising margins, reducing employee turnover, etc.
The more numbers you offer the better. This is easy in a role like Sales, but can be difficult in roles that aren't as clearly tracked. Whatever role, you must translate how the work you did impacted the bottom line so they know that you understand its value. To quantify this, ask yourself "What would happen if I didn't do my job?"
If you’re an Office Manager, what if you didn’t maintain the inventory, track expenses, and ensure all shifts were covered? Bad things happen. So on your resume summarize: "Negotiated a supply of $350K in inventory for a retail business with three locations across New England to meet the demands of our customers while remaining competitively priced."
When you’re good at your job, it can be difficult to see everyday tasks as accomplishments. But imagine what could go wrong if you weren't doing it.
Don’t expect interviewers to connect the dots of your tasks from past roles to their open role. Clearly do this for them.