Early Phase

We understand the challenges

Early phase (I to IIb)/ POC clinical trial delivery

This phase of clinical development continues to be seen as the critical step in successfully bringing a product to market. Both Pharma and Biotechnology companies recognize that the data generated at this stage will drive go/ no go decisions to enter Phase III. Furthermore, for some companies, it will determine their continued existence as they seek to secure future funding. At Cmed, we share our customers’ focus on early phase studies and understand both the importance and the urgency of delivering such studies.

As a direct result of the high profile of early phase clinical data, these studies have increased in size, complexity of design and number of endpoints. Cmed has been built to meet these demands.  Our strengths lie not only in the successful delivery of both innovative and traditional phase I to IIb patient trials, but also in their design.   As a result of this specialization, we have gained considerable experience and expertise in the delivery of early phase (I to IIb) and proof of concept (POC) clinical projects and remain at the forefront of early phase clinical trial innovation.  Over the last ten years, we have conducted more than 500 clinical trials of which 75% have been in clinical phases I to IIb/ POC.  These studies include:

  • Complex oncology studies and programs
  • Bayesian/ Adaptive designs
  • Evolutionary CRF designs
  • Proof of concept/ principle
  • Complex translational medicine studies
  • First in human, patient, PK and dose escalation projects

In particular, we focus on capturing clinical data in real time by using encapsia, our new generation clinical data suite, to improve early phase study execution.

  • All data is securely stored in the cloud and available over the internet to any location
  • Data is instantly availability for safety trend analysis
  • Data is instantly available for study oversight and management, speeding up important decisions like dose escalation

The full power of encapsia is unlocked when using encapsia eSource:

  • Replaces paper source documents and CRFs
  • Source data is stored electronically the moment it is recorded - it cannot be misplaced and all updates are audit-trailed
  • Validation occurs at the point of entry, during the patient visit, allowing errors to be identified and corrected immediately
  • Sites are not asked to transcribe source data into another system, eliminating this burdensome work and the errors that result
  • Patient eligibility can be confirmed prior to randomization or enrolment
  • SDV of CRF data is eliminated, slashing monitoring costs

Want to learn more?

Please feel free to contact us if you would like to learn more about our skills and experience. We are friendly, open and here to help.

Contact us