Phase I Clinical Trial Services

Quanticate supports studies in all phases but recognizes the importance of phase I 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.

Standardisation and efficient delivery

We incorporate standardisation 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 centralised clinical and 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 I. We 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, 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 modelling of complex PK/PD relationships.

Evaluating each dose and ascertaining the maximum tolerated dose
PK/PD modelling to characterise drug effects
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 UK, US and mainland Europe
Strong medical writing experience in Phase 1 protocols, CSRs, safety narratives
Close integration across Data Management