Early development and innovation

A multidisciplinary approach is the most cost-effective way to navigate early phase complexity and mitigate risks, and quickly transition to later phase development.

-Oli Fuhrmann, Executive Vice President, Head of Early Phase Development and Regional Head, Clinical Research Innovations, Europe

Early clinical development needs to move fast and deliver the right data to inform critical decisions and build a strong foundation for future success. Rely on Parexel to effectively integrate a breadth of disciplines to navigate complexity and optimize study designs and conduct to accelerate decision-making and determine the best course for your asset . 

• Regulatory expertise – Expert guidance on global regulatory strategies and early engagement with regulators before initiating a clinical development program – including advice on the best opportunities for fast track/breakthrough therapy designations.
• Translational medicine – Application of genomic expertise and state-of-the-art methodologies to help clients deliver novel therapies that treat patients based on their unique genomic and biomarker characteristics.
• Clinical pharmacology CoE – Scientific, operational and regulatory expertise in support of study designs, analysis of data and interpretation of study results, strategies for development and registration of drugs in various indications in all major regulatory regions. 
• Model-informed drug development – Quantitative science solutions to guide clinical trial design, dose selection, and target population identification.
• Global site network with embedded early phase clinical units – Offers comprehensive capabilities and flexible solutions for studies involving healthy volunteers, niche populations and patients from first in human to proof-of-concept.
• Portfolio due diligence and clinical development strategy – Acceleration of emerging science into promising assets backed by actionable development and commercialization strategies. Clinical development planning and program oversight ensures efficient, connected development from early phase to regulatory submission.

Early insights for more productive development

• As a leader in biopharma strategy and clinical development services, we can map out the path to regulatory and commercial success, beginning with asset prioritization strategies, and target product profile (TPP) development through early scientific consulting to clinical development plans. 
• Translational medicine encompasses advances from the search for useful biomarkers to biosimulation of disease systems, to use of DNA profiling in clinical trials.  At Parexel, we use next-generation analytic tools and technologies to help clients identify diagnostic, prognostic, and predictive biomarkers that can be validated in subsequent development. 

Regulatory strategies that make a difference

• Tap into our insider ‘know how” to make the most of early engagement meetings with regulators and minimize the potential for development delays. These consultations are as critical to success as a pre-new drug application or pre-marketing authorization application meeting. Parexel’s regulatory consulting team help clients prepare for these high-impact early advice meetings. Decades of regulatory expertise make Parexel particularly effective when guiding sponsors on how they can best use fast-track/breakthrough therapy designations. 
  
  100+ IND/IMPDs and 80+ meetings with the authorities are covered annually by our team of regulatory experts
• With a breadth of experience in clinical, nonclinical and CMC, regulatory experts review and assess available data based on their extensive experience with similar development programs to evaluate any potential gaps in data packages for regulators and recommend action to fill each gap, ensuring smooth development progression.

Capabilities and innovation to enable smarter and faster studies

• Advanced techniques - We advise clients to use all the available preclinical pharmacokinetic and pharmacodynamic (PK/ PD) data to predict human PK/PD.  Using quantitative approaches, our modeling and simulation team helps client optimize the development of promising candidates and eliminate weaker ones earlier in development. In some cases, modeling and simulation can support trial design or fully replace an early clinical study.
• Global early phase partner ecosystem with embedded early phase clinical units -- From first-in-human to patient studies, rigorous oversight from experienced staff and global state-of-the-art facilities, supported by standardized procedures provide the right environment to protect patient safety and deliver integrated data. Our early phase site network includes more than 50 sites across five continents.
• Deep expertise in the use of adaptive designs and integrated protocols that combine sequential early phase studies into a single protocol  to accelerate go/no-go decision making.  Parexel’s experience extends beyond design into the operationalization of protocols that are both precise enough to satisfy regulatory requirements and flexible enough to allow the lessons learned in each step to be applied to subsequent cohorts.
• As a pioneer in the design and conduct of ethnobridging studies involving Asian populations, we’ve expanded this approach as a cost-effective way to include other sub-populations in early phase studies.