Quantics can support you through
all clinical phases.
PK & PD Analysis
Quantics are experienced in Pharmacokinetic (PK) and Pharmacodynamic (PD) analyses. Our expert team of statisticians are on hand to ensure your knowledge of your drug’s PK and PD properties is sufficient to satisfy regulatory requirements.
We can also directly support applications to regulatory bodies, both by conducting analyses, and presenting data/code to required standards.
Quantics is very experienced in many different types of study design, in many different clinical areas with a specialisation in both invasive and noninvasive medical device trials
We can provide a report on the pros and cons of particular designs including adaptive models and other complex designs to ensure that the trial gains the maximum information at minimum cost.
Quantics has also had experience of respiratory, oncology, dermatology, cardiovascular and gastro-intestinal studies.
Sample Size Calculation
Sample size calculations are vital to clinical trials. With average per patient costs of a Phase 3 trial of $40,000, minimising the numbers required is very important. Too big a sample wastes time and money, but reducing the number too far may result in the entire trial being wasted.
Sample size calculations are based on a set of assumptions about what the trial is expected to show, based on historical data. Quantics has extensive experience in this field, and can provide a comprehensive report on the impact of varying the assumptions on the sample size and likely trial success, enabling you to balance the risk of trial failure against cost and recruitment time. We can explain the options with risks and consequences in ways suitable for scientists and financial supporters.
We have experience to help you in all of the following areas:
Exploratory studies / descriptive studies
Non-inferiority or superiority studies
- Choice and justification for non-inferiority margin
Designs involving data monitoring committees and interim analysis
- Impact of data monitoring committee decisions or interim analyses on sample size (power) of the study – does it need to be modified?
- Stopping rules
If there is not enough historical evidence about the expected performance of a clinical trial to be reasonably confident in the design, an adaptive trial can be designed. An adaptive trial monitors the outcomes of interest as the trial progresses, and uses this information to adjust trial parameters such as sample size, prescribing schedule, doses used, or patient selection criteria.
If this is to be done, the adaptive process MUST be fully defined in the protocol prior to the trial start and can not be subsequently changed.
Details of the adaptive process need to be masked from investigators to maintain blinding and Quantics, as an independent statistical consultancy, can design, monitor analyse and direct changes for an adaptive trial without risk of un-blinding.
Quantics can undertake full trial statistical analysis and provide appropriate reports for the Final Study Report, all to CDISC and GCP standards.
We can work with SDTM data from Data Management companies, provide ADaM and define.doc data sets, and all required documentation.
Interim Safety Analysis
Interim analyses and data monitoring committee meetings need to be planned and defined in the SAP. In particular it is important to define what data is to be reported, whether it is to be unblinded, and how the consequences of any decisions made will be implemented, and what the implications may be on the power of the study and required sample size.
Quantics can provide completely independent analysis, allowing unblinded results to to be examined without risk of unblinding of investigational staff. Quantics staff can also be part of the review group if required.
Quantics can provide a completely independent review of CRO proposals to address your core concerns:
- Is the overall study design appropriate for the objectives?
- Is the protocol sufficiently consistent and well specified to allow results to be calculated without ambiguity?
- Is the SAP consistent with the protocol and are the techniques proposed appropriate?
- Does the SAP specify management of special aspects such as population groups, missing data?
- If a data monitoring committee or interim analysis is planned,
- Are the requirements specified?
- Has management of consequent decisions been specified?
- Does the CRF capture the information required for the analysis?
- Is the information captured by the CRF in the most efficient form for the analysis?
Regulatory Submission Support
Quantics has extensive experience discussing statistical issues raised in the design stage or at NDA stage with regulators including MHRA,FDA, EMA, PMDA.
ISS and ISE
ISS and ISE stand for integrated summary of safety and integrated summary of effectiveness, respectively. These are not merely summaries, as the name might suggest, but rather documents comprised of integrated analyses of the safety and effectiveness of a study drug. In other words, the results from all clinical trials performed on the study drug are pooled together and analysed as a whole, producing combined statistical results. Quantics have a good understanding of the challenges and regularly work on projects in this area.