datamagik

Experience

Data Magik has, to date, worked with more than 45 companies from the UK, Europe, Japan and the US and completed in excess of 90 clinical studies.

Our clients range from small biotechnical companies and clinical research organisations to large multinational pharmaceutical and medical device companies.

Our therapeutic expertise is extensive and the list includes: Central Nervous System (CNS), Cardiovascular (Stroke, Hypertension, Arrhythmias, Peripheral Vascular Disease, Pulmonary Arterial Hypertension), Dermatology, Reproductive System (Menopause, Fertility Control), Renal Dialysis, Oncology, Analgesia (Arthritic Pain, Chronic Pain, Migraine) as well as Medical Devices (Stents, Joint Replacement Screws).

We have built a considerable reputation in CNS particularly within Alzheimer’s Disease (AD), Mild Cognitive Impairment (MCI), Parkinson's Disease (PD), Schizophrenia and Depression where we have applied specific adaptive design methods..

We also specialise in Phase I trials where we also have considerable experience with other novel statistical designs.

Our Special Interest Areas Include:

Central Nervous System (CNS)

Analysis of many trials specifically investigating the value of compounds in the treatment of Mild Cognitive Impairment (MCI), Alzheimer’s Disease (AD), Parkinson's Disease (PD) and Schizophrenia.

Collaboration with EU and US pharmaceutical and biotechnology companies to evaluate Alzheimer’s Disease (AD) compounds in Phase I, II and III development. These programmes involved bioavailability, dose ranging, efficacy and safety evaluations including a range of pharmacokinetic, biomarker and cognition variables

Utilisation of novel statistical designs such as group sequential/interim analyses in order to ensure early termination of ineffective doses and therefore efficient use of limited budgets

Extensive experience with cognitive function tests and ‘test batteries’ including: CDR, Cogstate, Cantab, Cogtest, the NTB and a variety of other pen and paper based tests.

Provision of advice to clients on CRO selection/supervision to the use of suitable methodology for assessment of symptomatic treatment and disease modification for AD.

Production of critical summaries of AD drug development programmes to assist with out-licensing opportunities.

Responsibility (through Shire Pharmaceuticals) for the statistical design, analysis and reporting of the Phase II programme for galantamine (Reminyl®) and the subsequent design of the Phase III studies with Johnson and Johnson.

Collaboration with Consultant Neuropsychologist to combine digital pen with selected cognitive tests to enable quick, accurate and valid assessment of changes in patient memory (www.Manentia.co.uk)

Many publications and presentations are available on request. Notable presentations include: The Review Of Methods For Analysis Of Alzheimer’s Clinical Trials (2007) and Adaptive Designs In Alzheimer’s Clinical Trials (2008)

Phase I Trials

Pharmacokinetic (PK) evaluation, including bioavailability or bioequivalence after single and repeat dosing

Pharmacodynamic (PD) or Biomarker evaluation

Many other study designs such as: ‘First into man’ studies, Dose titration or Dose selection as well as specific safety evaluations. A variety of statistical analysis methods have been used including:

Derivation and evaluation of PK parameters from individual drug level profiles either by compartmental or non compartmental modelling

Assessment of AUC and Cmax plasma curve parameters and determination of relative bioavailability and/or bioequivalence

PK and PD relationships investigated using regression analysis, correlations and various plots

Dose selection, using the Continual Reassessment (Bayesian) Method (O’Quigley)

Population pharmacokinetic parameter estimation and evaluation of differences for different patient groups providing sparse data, using Non Linear Mixed modelling approaches.

We provide statistical consultancy to Phase I units in Plymouth and Cambridge UK.