Phase II - IV Clinical

QPS Qualitix participates in the enrollment of trials with new drug candidates for diverse therapeutic areas.

The table below demonstrates the scope of QPS Qualitix’ experience in recruiting study subjects.

Phase Type Indication Study Main Purposes # of Subjects # of Sites Services
Phase II HIV To evaluate the safety and tolerability of two multi-dose regimens of a new drug candidate in asymptomatic HIV-1 infected subjects 22 2 PM/CR/
RA/PV/B
DM/MR
Phase II POAD To compare the improvement in initial claudication distance (ICD) between two new drug candidates after 16 weeks of treatment in patients with chronic peripheral arterial occlusive disease (PAOD). 50 2 PM/CR/
RA/PV/B
DM/MR
Phase II T2DM The objective of the study is to investigate the efficacy, safety and tolerability of a new drug candidate given for 52 weeks in treatment naïve and metformin treated patients with T2DM with insufficient glycemic control 48 7 PM/CR
/RA/PV
Phase III NSCLC To investigate the efficacy and safety of a new drug candidate compared to gefitinib as first-line treatment in patients with locally advanced, recurrent or metastatic EGFR mutation positive adenocarcinoma of the lung 40 6 PM/CR
/RA/PV
Phase III COPD The primary objective of the study is to evaluate the efficacy and safety of a new drug candidate compared with placebo, all administered once-daily (QD) via a novel Dry Powder Inhaler over a 24-week treatment period in subjects of Asian ancestry with COPD 80 8 PM/CR/
RA/PV
Phase I HCV To evaluate the safety, tolerability, and PK profiles of a new drug candidate after 3 days of oral dosing in hepatitis C (HCV) genotype 1 infected patients. 18 2 CR and
BDM
Phase I/II Solid Tumor Dose escalation trial of weekly intravenous administrations of a new drug candidate in patients with advanced solid cancers with repeated administrations in patients showing clinical benefit. 72 3 CR
Phase III T2DM The primary objective is to demonstrate non-inferiority of treatment with a new drug candidate in comparison to glimepiride in patients with type 2 diabetes mellitus [T2DM]. 150 15 CR

Abbreviations

PM = Project Management

CR = Clinical Research (including Clinical Research Associate, Regulatory Affairs Associate, Safety Contact and Project Manager)

RA = Regulatory Affairs

PV = Pharmacovigilance

BDM = Biostatistics and Data Management

MW = Medical Writing

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