FAQ

GCP CLINICAL TRIALS DIVISION

Selecting a CRO for your trial can be a daunting task. Many online articles and posts address some of the more obvious questions.

Here we take a different approach. We would like to focus on the questions that demand we answer with more questions. Because we believe every client, project or clinical study is unique.
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Some will tell you “One size fits all.” Others may boast their large size and scale, while others claim that they are “small, ‘boutique’ CROs.” So what’s the right answer? Honestly, they are all right.

Whether your company is large or small, it has its own culture and its own set of priorities. At GCP, we know that flexibility and agility are key to meeting our client’s needs. Some projects require a global network of partners to scale for multinational, cross-cultural, multisite trials. Another will need deep vertical expertise in specific therapeutic area. A breakthrough medical device startup may need serious handholding.

Bottom line: we understand you want the project to run smoothly.

Call us and let’s talk about our experience working with a company like yours. Bear with us when we ask probing questions that focus on your specific needs.

Do not be tempted by a quick response like “the day after tomorrow.” We believe in well thought out, built-in milestones to meet timelines-based analysis of your needs. Our promise: clearly set expectations ahead of time so we are all held accountable to delivering on time and on budget.

We are committed to building an integrated team for every project, with experienced professionals who know how to work together. We believe our fully integrated project team should function as an extension of your team. Today’s CROs have many of biopharmaceutical industry’s best and brightest on staff. But there is more to building trust than expertise. Integrated project teams and sponsor management must be able to work together in a delicate balance of trust and respect.

Every customer is assigned one project manager, carefully selected based on your specific project’s needs. This project manager is singly dedicated and committed to coordinating and leading your project. Our project managers never juggle too many studies at once, and will never lack the time to provide regular communication to sponsors. This is true all the way to the top. Senior GCP management is always available and remain engaged in ongoing projects from A to Z.

It’s important to have a discussion to understand your needs in order to provide the required services. In Israel, our services are provided by our own employees. Outside of Israel, we work through a network of alliances, managed by our own project managers. Having all the services under one roof streamlines project management and makes it easier. 

We manage our clients’ studies in accordance with our own Standard Operating Procedures (SOPs), and if needed, we can align with our clients’ SOPs as well. Our quality manager regularly trains and supervises all staff. We are proud that over the years our SOPs have successfully passed rigorous audits. We have also successfully passed FDA inspections. And of course, it is no mistake that our company’s name stands for Good Clinical Practices. It is what we stand for. It is what we teach. It is behind everything we do.

We are totally committed to meeting deadlines and delivering results within your budget. We do this by developing and closely managing clinical finances, timelines and resource allocation after mapping out all the trial parameters, such as the number of sites, subjects, enrollment period and monitoring. We set timeline and key milestones, and budgets are based on deliverables, as are our monthly invoices. In our experience, we execute change orders to budgets only in cases where additional sites are added, or extend timelines when a sponsor request this.

Of course! We are happy to connect you with our clients to share their experience working with us.

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