The gig economy has exploded in popularity over the last decade, thanks in part to the Great Recession. At the end of 2009, up to 15 million Americans found themselves out of work and looking for ways to pay the bills.

Apps like TaskRabbit, PostMates, and Uber all launched during the same time. These platforms presented something unique –– reliable work opportunities, flexible scheduling, and the chance to be your own boss.

For years, business experts predicted that the gig economy was a flash in the pan. But that’s looking less and less likely. According to Statista, the Global Gig Economy is here to stay, as exhibited by its rapid growth. 

Consider this –– in 2018, the gig economy accounted for $204 billion globally. In 2023 that number is projected to more than double to $455 billion.

Often, discussions of the gig economy focus on its benefits to individual workers. But those advantages also apply to clinical trial sponsors and other decision makers. Though you might not associate the gig economy with your vendor selection and management needs –– you should! 

At Harbor Clinical, we’ve found a way to apply the gig economy model to GxP auditing. In this white paper, we discuss our GxP auditing program and highlight how it benefits both sponsors and auditors.

Harbor Clinical: Applying the Gig Economy to GxP Auditing

As a clinical trial sponsor, there are a lot of things to consider. One of the most crucial is maintaining quality control. Without a system in place for regular audits, there is the potential for noncompliance and other problems to arise. Even if you routinely perform internal reviews, partnering with an independent third party can provide additional peace of mind.

As a functional service provider (FSP), we specialize in connecting part-time and full-time auditors with clinical trial sponsors. And, we provide our auditing services in a unique way. Specifically, we use a gig economy model to help you plan, schedule, manage, and conduct site and vendor audits.

By partnering with our auditing experts, you can ensure compliance in any location against an array of good practices, including GCP * GDP * GVP * GLP * GMP * GCLP * CSV. We can even assist you with specific audit types, including:

• Vendor/Site Qualification

• Vendor/Site For-Cause

• eTMF/TMF Documentation

We ensure all of the auditors we work with, whether provided by you or Harbor Clinical, adhere to all applicable standard operating procedures (SOPs) guaranteeing quality assurance.

How Does the “Gig Economy” GxP Auditing Model Benefit Trial Sponsors?

Partnering with Harbor Clinical to conduct site and vendor audits, can benefit your study in several ways, including:

Increased agility. We have part-time and full-time subject matter experts (auditors) located all over the world. No matter your requirements, we can quickly assign an auditor, even with short notice. Further, we can reassign auditors as your needs change.

Reduced costs. When you rely on a third party (like us) to handle GxP audits, you don’t have to hire a full-time, dedicated auditing staff. Just think of all the money you’ll save not having to pay vacation or benefits.

Improved access to auditing professionals. Good GxP auditors are hard to find. We thoroughly vet each of our experts and present only the best.

Enhanced compliance. Bringing a new drug or biologic to market is rife with potential risks. An outside auditor can verify that you’re compliant with all rules and regulations, preventing delays, penalties, or fines.

How Does the “Gig Economy” GxP Auditing Model Benefit Auditors?

Our GXP auditing model saves sponsors money, increases trial agility, and enhances GCP compliance, but it also benefits the auditors with whom we partner. 

By becoming a part-time or full-time Harbor Clinical auditor, you’re able to:

Create your own schedule. We’re always looking for subject matter experts, including GxP auditors, to join our team. We hire both part-time and full-time consultants. Simply set your hours and we’ll send the work to you.

Choose projects that interest you. As an auditing consultant, you have the option to work on as many (or as few) projects as you like. Each week, we send out audit dates and locations. You can review them and then select the audits you’re most interested in.

Build on your professional skills. At Harbor Clinical, we partner with dozens of clients across the pharmaceutical industry. As an auditing consultant, you can follow your passion, expose yourself to new sponsors and vendors, and immerse yourself in new processes and systems.

Expand your professional network. We’ve developed strong relationships with nationally and internationally renowned biotech and pharmaceutical companies. This eclectic mix of opportunities exposes our auditors to professionals they might not encounter otherwise.

The Gig Economy and GxP Auditing: Experience the Harbor Clinical Difference

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 maximizes earning potential.

Request a GxP Auditing Consultation today. Send an email to [email protected] or schedule a meeting directly at https://meetings.hubspot.com/harborclinical/meeting