A critical step on the road to regulatory approval and market launch, Clinical Development begins after the Discovery Phase and proof of concept.

To navigate this phase successfully, you need a multidisciplinary strategic plan that establishes the objectives of your clinical program. It should also align with your requirements and non-clinical/pre-clinical data whilst at the same time ensuring you meet regional regulatory requirements that align with commercial plans.

Your clinical program should be appropriately powered to allow you draw valid conclusions, but a balance with study size is required to ensure the development costs are controlled. It is also important to take real world evidence and market access into consideration as you work out clinical protocols and synopsis design.

During the course of a drug’s clinical development, continuous review of the incoming trial data is also a key factor in avoiding delays and reducing costs.

Smart & Streamlined

Given our expert understanding of the clinical, regulatory and competitive landscape, PharmaLex is perfectly positioned to offer smart strategies and tactics for drug development across the entire therapeutic spectrum.

Our expert statistical analysis team offers support with the design of streamlined yet powerful statistical analysis plans.

Our comprehensive approach meets the holistic needs of start-ups, venture capital funded firms and small to mid-size biotech companies, while our targeted expertise helps large pharmaceutical companies with specialized development needs.

In keeping with our aim to deliver innovative solutions, we use proprietary software that streamlines wherever possible—including automating redaction, transferring analytical methods between labs or validating bioassays and physico-chemical methods.

Big Data & Beyond

From data science to clinical trial applications, orphan drug designation to statistical services, scientific writing to IMP management, our broad range of services covers every eventuality.

We’re ready to help you:

  • Analyze clinical trial data accurately to guide future trial and development decisions
  • Optimize study design and clinical protocol with biostatistics
  • Improve clinical development programs with randomization, statistical analysis and study powering
  • Define TPP to support the target label
  • Manage global development programs for tissue, cell and gene therapy products, biosimilars and new biologics, pharmaceutical and orphan drugs
  • Implement early phase modeling to schedule development activities at their most effective point
  • Support business development with portfolio reviews and asset repositioning

Success Stories

We’re proud to support clinical development programs around the world.

Here are a few examples:

Using Bayesian modelling, PharmaLex developed a fast decision-making tool for clinical trial recruitment

that ensured target patient numbers were achieved and helped to reduce unnecessary costs from delays.

PharmaLex provided integrated technical, development and regulatory support for the product development of a novel Vitamin K-based therapy

for arterial stiffness in renal transplant patients in the US which resulted in successful seed funding, agency support, scale-up of manufacturing and investor packages for secondary financing.

If you’re looking for effective input on your clinical development program, schedule a call with us today!

PharmaLex. Confidence beyond compliance.