It’s hard to believe, but 2023 is soon coming to a close. With the new year right around the corner, now is the perfect time to start thinking about and planning for your GxP vendor audits. Dealing with audits can leave sponsors feeling stressed and anxious but these reviews are essential to your success. They present an opportunity to ensure your vendors are complying with all rules and regulations and help you identify potential risks and opportunities for improvement.
Instead of stressing about something that has to be done, why not make the most out of the experience? This can seem like an impossible ask if you like being in control, but GxP auditing doesn’t have to be daunting. Thanks to innovations during the last decade, it’s possible to complete the process quickly and efficiently. The key? Partnering with a CRO that embraces the gig economy.
The Gig Economy: A Brief Overview
Many people think that the gig economy is something relatively new, but it’s actually been around for decades and has grown exponentially since the midst of the Great Recession in 2008. During that time, many people lost their jobs, were dealing with underwater mortgages and other hardships and searching for a way to make ends meet. Those economic headwinds caused millions of Americans to look for reliable sources of income quickly.
At the same time, internet connectivity reached record levels, meaning it was easier than ever for people and businesses to connect. Entrepreneurs responded to this technological revolution by launching new platforms providing something unique and in demand –– reliable work opportunities, flexible scheduling, and the chance for workers to be their own boss.
Gig workers face unique challenges, but the format is here to stay. In fact, the industry is growing at a rate of 17% annually and will contribute $455 billion to the U.S. economy this year alone.
Many gig economy discussions focus on its benefits to the contractors, but those advantages also apply to the employers and the fractional business model is continually expanding into different industries. CROs are starting to embrace the model, which has the potential for bringing new drugs and therapeutics to market sooner.
Case in point: Harbor Clinical. We’ve incorporated the gig economy into our GxP auditing processes. Keep reading to see how our unique GxP auditing approach benefits sponsors and auditors alike.
Harbor Clinical: Applying the Gig Economy to GxP Auditing
As a trial sponsor, there are lots of things to consider and one of the most crucial is maintaining quality control. Without a system in place for regular audits, things are more likely to fall through the cracks. Even if you routinely perform internal reviews, partnering with an independent third party provides a second set of eyes and peace of mind.
As a functional service provider (FSP), it’s our job to connect part-time and full-time GxP auditors with trial sponsors. And, we provide our auditing services in a unique way. Specifically, we have applied the gig economy model to help sponsors plan, schedule, manage, and conduct site and vendor audits.
Our auditing experts ensure compliance in any location against an array of good practices, including GCP * GDP * GVP * GLP * GMP * GCLP * CSV. We also offer assistance with specific audit types, including:
- Vendor/Site Qualification
- Vendor/Site For-Cause
- eTMF/TMF Documentation
Our auditors are highly qualified and go through an extensive vetting process to ensure they adhere to all standard operating procedures (SOPs) guaranteeing quality assurance.
How the “Gig Economy” GxP Auditing Model Benefits Trial Sponsors
Partnering with a company like Harbor Clinical to conduct third-party trial audits, offers various benefits for your study, including:
Increased agility. We work with part-time and full-time subject matter experts (auditors) all over the world. No matter your location or requirements, we know what it takes to increase or decrease your workforce to rapidly meet the demands of your trial.
Increased efficiency. Partnering with a third-party organization like Harbor Clinical for GxP audits saves you the hassle of finding and interviewing candidates. Consider that hiring a new employee takes 36 to 42 days, and costs $4,700 on average and those numbers quickly balloon if you need talent with specialized expertise.
Improved access to auditing professionals. Good GxP auditors require special knowledge, training, and expertise. These professionals can be hard to find if you don’t know where to look. At Harbor Clinical, we’re lucky enough to have a deep talent pool to draw from and we thoroughly vet each of our GxP experts.
Enhanced compliance. Bringing a new drug or biologic to market is a long and tedious process. Not to mention expensive and risky. A qualified GxP auditor can verify that you comply with all rules and regulations, preventing delays, penalties, and/or fines.
How The “Gig Economy” GxP Auditing Model Benefits Auditors
Our GXP auditing model increases trial agility, enhances GCP compliance and saves sponsors money but it also benefits the auditors we collaborate with.
By becoming a part-time or full-time GxP auditor (consultant), you can:
Be your own boss. We’re always looking for qualified subject matter experts. We hire both part-time and full-time GxP auditing consultants and the hours are typically flexible based on your schedule and the needs of the sponsor.
Select jobs you’re passionate about. As a Harbor Clinical auditing consultant, you can work on as many (or as few) projects as you like. Job descriptions are regularly circulated to the appropriate parties within our GxP auditing network and you have the ability to select those that work best according to your bandwidth and level of expertise.
Hone your auditing skills. We partner with dozens of clients across the pharmaceutical industry. As an auditing consultant, you can follow your passion, learn new skills, and immerse yourself in emerging processes and systems. In other words, it’s an excellent opportunity for professional growth and refinement.
Connect with other professionals in the field. We’ve developed strong relationships with nationally and internationally renowned biotech and pharmaceutical companies. This eclectic mix of opportunities exposes our auditors to professionals and experiences they might not encounter otherwise.
The Gig Economy and GXP Auditing: Experience the Harbor Clinical Difference
“The best collaborations create something bigger than the sum of what each person can create on their own,” – Anonymous
The above quote emphasizes the importance of teamwork and the gig economy makes collaborations easier to achieve. For sponsors, our unique approach to GxP auditing saves money, better allocates resources, and keeps studies on track. For auditors, it increases flexibility, builds professional networks, and ensures a steady paycheck.
With 2024 fast approaching, now is the right time to reevaluate your vendor auditing processes and begin planning. Our unique, customer-centric approach emphasizes collaboration to ensure all of your bases are covered.
Interested in learning more? Request a GxP auditing consultation today. Call (781) 775-0342 or send an email to [email protected]. We’d love to learn more about your needs and help make 2024 your best year yet!