Biotech companies face many challenges when they begin their development journey. These hurdles can make or break a molecule’s future. Finding out that your clinical research organization can’t cut it halfway through the process is enough to derail even the most successful drug program.
By outsourcing carefully at the start, you can find one strategic, effective partner to help guide you through the entire process.
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Worldwide Clinical Trials offers full-service assistance, from mid-preclinical phases to commercialization and beyond. By working with a partner that is just as skilled in the nitty-gritty details and infrastructure of early development as it is with late-phase trials, regulatory requirements, and market access, you can get a customized, strategic roadmap to get you where you want to go.
When the development process hits inevitable bumps in the road, having the right CRO partner makes all the difference. Knowing how to navigate new hurdles, re-envision the development process, and strategically align with regulatory and industry requirements can help your molecule maximize its success premarket so that it’s ready for an impactful launch. A nimble, responsive, experienced CRO can help you avoid major pitfalls and adjust intelligently to any challenge.
There’s a lot that goes into drug development. Having a single partner you can rely on – who knows your drug and company strategy inside and out – means each part of your journey is done with care and forethought about the impact on both the present and future of your program. It also results in fewer interruptions and delays, a more predictable development and regulatory review process, tighter budget control, and a more responsive, in-depth relationship with your CRO.
From start to finish, Worldwide is the one full-service CRO who can truly work as a thoughtful, engaged, responsive partner through the entire range of services you require.
Our Clinical Pharmacology Unit and integrated Bioanalytical Laboratory are located near each other to allow for rapid sample processing and data generation.
Biotech firms with a molecule ripe for study can benefit from a strategic research partner sooner rather than later. Our Clinical Pharmacology Unit and integrated Bioanalytical Laboratory are located near each other to allow for rapid sample processing and data generation. Each facility offers leading-edge technologies, advanced clinical and analytical services, and extremely high quality. From protocol concepting and scientific consulting to IND support, and from data and project management to multi-site, first-in-human pharmacokinetic and clinical monitoring, our preclinical and early-phase services take the guesswork – and the hassle – out of moving from preclinical to early clinical phases.
Sherilyn Adcock, PhD., RPh.
Chief Scientific Officer,
Early Phase Development
Senior Vice President, Head of Clinical Pharmacology Services
Our team is constantly on the lookout for efficiencies and opportunities to make your data, budget, and efforts go further through strategic planning and proactive communication with regulatory and program stakeholders.
Once clinical research is underway, you can rely on our broad team of experts to diligently manage your drug development program. Our team is constantly on the lookout for efficiencies and opportunities to make your data, budget, and efforts go further through strategic planning and proactive communication with regulatory and program stakeholders. Advanced biostatistics support, our global network, access to our leadership, and intelligent, adaptive approaches to challenges provide you with the best partner to navigate the difficult road toward approval.
Michael Murphy, MD., PhD.
Chief Medical and
Senior Vice President, Global
Site Management & Trial
We understand that the end goal doesn’t exist in a vacuum. It involves hitting lots of strategic targets along the way.
The end goal for each client may be different. Whatever your strategy – finding a buyer, partnering with big pharma, or marketing the drug yourself – Worldwide can help you get there. That’s because we understand that the end goal doesn’t exist in a vacuum. It involves hitting lots of strategic targets along the way. Through early and ongoing discussions with regulatory bodies, and strategic planning throughout the entire development program, we help ensure our clients and their molecules are prepared for the rigorous review process.
And our services don’t end at a successful product launch. We offer continuing support through real-world evidence gathering, patient-reported outcomes studies, health economic and outcomes research, economic dossiers and modeling, safety surveillance, literature reviews, and more.
Global Head of Regulatory
Jeff Trotter, MBA.
Senior Vice President, Scientific Solutions, Real World Evidence
How do you turn an at-risk study into a successful clinical trial? This eBook will help you analyze the following aspects of your trial: Budget Timeline, Recruitment & Retention Study, and Personnel Rescue ReadinessREAD MORE