Klinische Studien

Have Questions?

• What is an FSP?

  FSP stands for functional service provider and is about delivering customized global solutions that enable clients to efficiently manage their clinical trial portfolio. This includes putting quality people, intelligent processes, and deep technical expertise in place to work directly on a client’s business. An increasing number of pharmaceutical and biotech companies are turning toward this model to decrease their overhead and make their operations leaner and more efficient. Covance FSPx® is the functional service provider you can rely on to deliver customizable solutions through strong collaboration and commitment to quality. Learn more about FSP.

• What are Decentralized Clinical Trials, Virtual Clinical and Hybrid Clinical Trials?

  The need to transition from a site-centric approach to a more patient-centric clinical trial model led to innovations that reduce patient burden by reducing the amount of travel needed, allowing more services to be performed at or near the patients’ homes and incorporate new ways of identifying and enrolling trial participants. First called “virtual trials,” meaning investigator sites would play little role, the industry rapidly learned that most trials would involve a hybrid approach, including both traditional and novel technologies. Now this spectrum of trials is usually termed “Decentralized Clinical Trials” or DCT for short. We deliver a patient-centric ecosystem of conveniently located resources all connected by a single technology platform. An example of a DCT model is our solution that includes connecting LabCorp’s U.S.-based Patient Service Centers, global partnerships with reputable retail pharmacies, as well as home health phlebotomy and nursing service providers, with a best-in-class technology platform. We can pair site-based patient recruitment with web-based direct-to-patient outreach. Learn more about DCTs.

• When should Phase IV trials be considered for drug development?

  Phase IV trials are conducted “in the real world.” As such, they can complement, and in certain circumstances, replace Phase III trials. If your drug is for a rare/orphan indication, a life-critical condition or where a Phase III trial would be considered unethical, a Phase IV trial may be preferable for regulators. For advanced cell and gene therapies, Phase IV trials and accompanying long-term follow-up studies should be considered. Learn more about Phase IV trials.

• How can Phase IV studies/trials, and Phase IIIb trials be combined to explore new indications?

  Exploring new indications for previously approved products requires an appropriate level of safety and efficacy data to be collected to satisfy regulators. Depending upon the target indication, a Phase IV study may suffice to generate the real-world evidence (RWE) needed. However, where more thorough investigation is required, a Phase IIIb clinical trial or a Phase IV trial may be required. Our aim is to maximize efficiency by working with you to determine the most appropriate approach for your product and target indication.

• How does Covance utilize proprietary data to improve clinical study outcomes?

  • Only Covance combines one of the world’s largest sources of de-identified lab results and patient intelligence data with investigator data from the majority of global clinical trials that provide insights to increase efficiencies and effectiveness in clinical drug development.
  • LabCorp Data – using LabCorp’s real-world, de-identified clinical laboratory data on over 150 million patients, we can assess populations who meet your protocol’s eligibility criteria and accurately model the impact that the protocol inclusion/exclusion criteria will have on the patient pool size.
  • Covance Central Labs Data - Covance generates more clinical trial data than anyone else in the world. Our global proprietary data helps us predict future investigator performance and capacity to run multiple studies.
  • Patient Direct – we have access to ~150 million patients and have a rapidly growing database of people who have given us permission to reach out directly to them for participation in clinical studies. Mehr erfahren.

• What is the Covance Integrated Clinical Pharmacology Solution?

  Drug development is a complex and challenging pathway to navigate. In today’s environment with ever more complex drugs and drug targets, it is essential to think beyond the four walls of a traditional clinical pharmacology unit in order to optimize early clinical development. An integrated development platform, including the resources, experience, expertise and infrastructure necessary to design and execute early clinical studies is an effective way of mitigating risk. A multidisciplinary team that understands the market and the molecule can devise a regulatory strategy and an early clinical development plan that aims to efficiently determine whether or not a drug candidate should continue to be developed. Effective use of the integrated platform allows for efficient determination of whether or not the drug achieves sufficient levels in the relevant physiologic compartment, whether it interacts with its intended target as anticipated and whether it has any unanticipated or otherwise untoward biological effects. Increasingly, this requires not only strong clinical pharmacology expertise, but also access to biomarker testing and project management staff that can guide a protocol seamlessly from cohorts of normal healthy volunteers in a clinical pharmacology unit to cohorts of patients at multiple investigative sites. Learn more about clinical pharmacology.

Covance-Einblicke

Wie sich der RACE for Children Act auf die Wirkstoffentwicklung in der pädiatrischen Onkologie auswirkt Webinar View this webinar to get insights spanning rare diseases, regulatory strategy, oncology and pediatric drug development. Find out about the current pediatric oncology drug development landscape and an industry-focused view of applicable regulations and the RACE for Children Act... Watch Webinar Mobile Gesundheit und hybride/virtuelle Studien zu Diabetes Webinar Inflammatory Bowel Disease Clinical Studies and the Importance of Patient Centricity Blog Angehen der Herausforderungen des Datenmanagements für Pharma- und Biotechnologieunternehmen: Einführung des Labors FSPx Blog

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