Clinical Pharmacology and Phase I in Drug Development

Introducing a drug into the human body for the first time is an important milestone. With so much at stake, human safety and early efficacy are now driving more go / no-go decisions than ever before. We focus on two critical aspects of your study — scientific integrity and human subject safety. 

Clinical pharmacology education center

When it comes to developing your clinical pharmacology studies for biologics and small molecules, you need a global partner that can get it done. As a team, we’ll work together to transform your preclinical safety data into robust protocols for Phase I safety in healthy subjects and patients.

Clinical pharmacology is the link between the preclinical data and the targeted population. Your team of scientists and clinicians put principles into action by closely monitoring testing, including preliminary evaluation of drug safety, tolerance and pharmacokinetics. As more information on your molecule becomes available, we'll scrutinize development progress and deliver unique insights for decisions.

As your drug moves toward registration, expertise across complex, specialty and standard studies can mean the difference between one partner and managing multiple vendors. You’ll have access to more than 316 beds at four sites across the United States and Europe. As one of the largest early-stage clinical research organizations in the world, you’ll find a study to meet your needs.

  • SAD / MAD (single-ascending-dose/Multiple-ascending-dose)
  • Adaptive clinical protocol design
  • Cardiac safety including definitive QTc/thorough QT (TQT)
  • Microdose
  • Human ADME – 14C Radiolabeled
  • Muscle biopsy
  • Ocular
  • Sleep
  • Vaccines
Clinical Pharmacology at Covance
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As you perform an increasing number of clinical Phase I studies in patient populations, it helps to have an ally with deep hospital partnerships. By collaborating with hospitals near our clinical research centers, we’re able to conduct high-quality first-in-human early clinical research in a safe and regulated environment. Together, we give you a powerful combination of expertise in patient access and specialist patient care at the Royal Liverpool University Hospital in the UK and the Indiana CTSI Clinical Research Center.

  • Social media
  • Local community outreach
  • Referral programs
  • Radio, television and online advertising
  • Call centers

Creating a positive study experience attracts repeat participation and generates referrals. 95% of our subjects would refer Covance to friend.