Expertise and Experience to optimize your clinical pharmacology program

An investigational drug’s clinical pharmacology program assesses a compound’s (absorption, distribution, metabolism, and excretion) ADME data and determines the need for Phase 1 label claim studies among other elements. These studies include food effects, drug-drug interaction (DDI), special populations, cardiovascular safety, and human mass balance with metabolite identification to name a few.

Typically, pharmaceutical companies engage a contract research organization (CRO) to design, conduct, and analyze their clinical pharmacology studies. On the surface, selecting and managing a CRO for this part of clinical drug development is straightforward provided the sponsor company has the necessary experience and bandwidth. However, oftentimes sponsors run into numerous challenges with this process including selecting the CRO that best meets your needs, managing study start up and conduct, and ensuring proper data management and analysis.

Certara’s Clinical Pharmacology team provides the CRO oversight needed to optimize clinical success.

Utilizing Certara’s Clinical Pharmacology Study Offering (CP Set), we can help ensure that your CRO does everything correctly, efficiently, and not more than is needed.

Clinical Research Organization Bidding

Integrate knowledge based on CRO experience and regulatory expectations to select the right Clinical Research Organization

Clinical Pharmacology team will perform an assessment of your program to identify CRO that best align to your program based on:

  • The therapy’s unique attributes
  • Potential clinical challenges
  • Budget
  • CROs experience in therapeutic area and indication
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An Innovative Strategy to optimize a CRO’s Offerings

Certara can work with a CRO on behalf of sponsor to increase clinical efficiency without sacrificing quality by:

  • Optimize trial design to reduce size and number of studies when applicable
  • Oversee clinical strategy to ensure all necessary measures are accounted for.
  • Work as an extension of a sponsor’s team to oversee entire clinical trial process
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We can help sponsors:
  • Ensure accountability of the CRO during the clinical trials
  • Increase trial efficiency to minimize the size, number of trials, and study durations when applicable
  • Reduce costs through use of advanced modeling & by ensuring only necessary services are provided
  • Communicate with CRO on sponsor’s behalf
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Julie Bullock,药学博士 副总裁兼临床药理学和转化医学部全球负责人

Julie 拥有 10 多年在 FDA 任职的药物开发经验,并为 14 项以上新的分子实体审批做出了贡献。她对儿科发展、用于生物制剂的 PK/PD 分析和方法、肿瘤学给药策略以及突破性疗法和加速审批的发展均有独特的见解。

我们能帮你什么吗?

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