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Clinical Trial Phases

Phase I Clinical Trials

Quanticate supports studies in all phases but recognized the importance of phase I clinical trials and the special attention that they require. We have an excellent team of experts in this clinical phase and have built up the experience and knowledge to offer a complete package covering all aspects of phase I trial delivery. This covers the rapid delivery of core safety elements as well as advice and support to more novel objectives of specific trial designs.


Standardization and Efficient Delivery

We incorporate standardization in procedures from CRFs to outputs to ensure quality and consistency with reduced cost and time. Significant savings come from tried and tested approaches and centralized clinical safety data.

  • Standard CDASH/CDISC CRF pages and datasets
  • EDC or fast turnaround of paper CRFs
  • Standard derived dataset specifications based around SDTM standards
  • A suite of macros that produce standard summary and safety outputs

 

Design Expertise

Good statistical study design can improve study quality and reduce the time needed to complete phase IWe offer the expertise to consider designs that cover all the standard aspects of phase I, including safety evaluation, the effect of food on exposure, potential drug-drug interactions, gender and/or age effects, alternative formulations, and bioequivalence. Beyond this, we are experienced in studies that consider evaluation of pharmacodynamic (PD) effects and other exploratory endpoints. Many of these objectives can be evaluated within one protocol, using a combination design.

  • Flexible designs that can eliminate the need for multiple studies
  • Combined single and repeat dose ascending designs, sequential/interlocking cohorts, ‘cocktail’ drug-drug interaction studies
  • Interim analyses and sequential designs

 

Statistical Analysis Expertise

We provide considerable expertise in the statistical analysis of phase 1 studies. As well as establishing the safety, tolerability and pharmacokinetics (PK) of single and multiple doses and ascertaining the maximum tolerated dose, our analysis may incorporate additional endpoints and include modeling of complex PK/PD relationships.

  • Evaluating each dose and ascertaining the maximum tolerated dose
  • PK/PD modeling to characterize drug effect
  • Vital signs, QTc evaluation, laboratory data
  • Pharmacodynamic and exploratory endpoints (PET, EEG, rating scales, etc.)
  • Analysis of data for dose escalation meetings

 

A Full Phase I Package

  • Long-standing partnerships with several Phase 1 units in the UK, US and mainland Europe
  • Strong medical writing experience in Phase 1 protocols, CSRs, safety narratives
  • Close integration across Clinical Data Management

 

Phase I Studies Medical Writing    Phase I Study Design

 


 

Phase II-III Clinical Trials

Quanticate has supported a wide range of global Phase II-III clinical trials in various therapeutic areas. We can advise on appropriate technologies and our IQ system enables easy visualization of data and metrics at a study and programme level.

Being a data-focused CRO, rather than a full-service CRO, we have extensive experience working with other CROs, vendors and customer teams. We are able to provide full data-related support, including clinical data management, biostatistics, statistical programming, medical writing and pharmacovigilance. In addition, we have experts that can support the study design in terms of patient numbers and risk-based approaches to monitoring. By optimizing study design and having easy access to cross-study data across the development program, Quanticate aims to provide solutions that meet the desired outcomes whilst remaining efficient. Our global capability by utilizing teams in the UK, US, India, Poland and South Africa, also enables us to keep costs at an optimal level at both an FTE level and overall relationship level. We have supported these types of trials both at a trial level and part of a larger scale FSP/CSP partnership.

 

PK PD Models   Bayesian Study Design

 


 

 Late Phase Clinical Trials

Many of the trials that we have supported have been phase IV studies or late phase clinical trial programs. These have ranged from small, single country marketing studies through to large global observational trials. In certain circumstances, we have also been able to support clinical monitoring in addition to the data and safety-related aspects of the trials.

We are able to advise on technologies, such as EDC and e-PRO, that can be utilized and offer expertise when developing the trial and defining patient and visit numbers to ensure statistical relevance. Being able to pool these data with those generated in other studies throughout the product development can also help to make better use of the data for decision making processes. Our Centralized Service Provision (CSP) approach, coupled with our IQ portal for data centralization and visualization can help this to happen more effectively and efficiently. We understand there are often budget and resource constraints for certain types of late phase studies and our aim is to offer the best solution within the designated budget, whilst maintaining quality and maximising outcomes.

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"Thank you very much for the document with the sample size calculations and especially for your additional thoughts on design aspects. This is very helpful and very much appreciated!"
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