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Early Clinical Development

Early Clinical Development

Many reports estimate that the total cost to develop and gain marketing approval of a new drug is about 1.5 trillion won for a lengthy period of 10 to 15 years. Even if large pharmaceutical firms and life science companies are spending a lot of time and money as a primary aim to develop blockbuster drugs that generate at least $1 billion in revenue a year, there are growing risks and economic losses on the part of drug developers due to today’s expanding regulations and costly clinical trials process. Under such circumstances, to curtail heavy clinical trial costs, many sponsors have introduced a variety of data analysis tools to utilize diverse predictive models in the initial drug discovery stage, as part of efforts to dispel any uncertainty and centralize their efforts on the new drug project with a high potentiality. As a proven clinical services provider with over 20 years’ experience and expertise, C&R Research offers reliable data and solution for clients so that they can make an optimal, timely decision in an early clinical development.

One-Stop Drug Development Process through Integrated Service

Q-fitter, Korea’s first and only pharmacometics services and early site management organization (SMO), is a business model commercializing the pharmacometrics that have been locally conducted in an academia setting as a small size until this date. C&R Research has built a service model integrating its 20-year accumulated capability of clinical trials with Q-fitter’s pharmacometics expertise and SMO technology. This model can provide an one-stop clinical trial process from the initial new drug development design to the latter phase of drug development, thus enabling clients to effectively reduce the amount of time and effort required for clinical development and providing assurance that their new drug R&D project can be successfully operated.

1. Early Phase Study
Drug-Development-&-Clinical-Phamacology
[ Early Phase Clinical Trial Operation & Management Services ]

With a workforce of experts having rich clinical experience and under organic collaboration with Q-fitter’s researchers, C&R Research provides an optimal, tailored clinical development solution to manage the client’s project via various approaches. In addition, by utilizing its human resource pool that has been firmly established among the industry, academia and government and other available resources, C&R Research will help clients conduct the early phase studies efficiently from Phase 0 to Phase IIa.

Phase I

Phase II

Others

[ C&R Research’s rich experience inearly phase study ]

Organic-collaboration-between-C&R-Research-&-Q-fitter
[ Organic collaboration between C&R Research & Q-fitter ]
2. Pharmacometric Anlaysis

In an effort to diversify the scope of its 20-year clinical services, C&R Research established Q-fitter in 2016. Since 2014, Q-fitter has been offering pharmacometrics consulting services to clients in initial clinical development and modeling/simulation in diverse therapeutic areas. Through such accumulated experience, C&R Research takes pride in providing reliable new drug R&D strategies for clients at all times.

Nonclinical to clinical trial translation
Compound Indication Purpose Modeling Practice
A Anti-cancer
(Cytotoxic)
Evaluation of anti-tumor effect
  • PK/PD
  • Tumor growth model
B Anti-cancer
(target)
Human starting dose escalation
  • Antibody PK-PD (TMDD)
  • Comparator drug
C Dislipidemia Human starting dose estimation
  • PK/PD (Dose proportionality)
First-in human trial design
  • Comparator drug
D Inflammatory
Disease
First-in human trial design
  • PK/PD (Dose proportionality)
E Anti-cancer
(target)
First-in human trial design
  • PK/PD
  • Tumor growth model
F Autoimmune Human starting dose estimation
  • PK/PD
G Anti-cancer
(target)
Human starting dose escalation
  • PK/PD
First-in human trial design
  • Comparator drug
  • Tumor growth model
H Anti-cancer
(target)
Human starting dose escalation
  • PK/PD
Nonclinical study design
  • Comparator drug
  • Tumor growth model
I Diabetes Mellitus
Type 2
Human starting dose estimation
  • PK/PD
  • Comparator drug
Next Step clinical trial translation
Compound Indication Purpose Modeling Practice
A Anti-hepatitis Evaluation of clinically-applicable dose
  • Antibody PK
  • Clinical decision-making criteria
B Dislipidemia MAD design
  • PK/PD (Dose proportionality)
  • Comparator drug
C Dislipidemia Prediction of Food Effect
  • PK/PD (Dose proportionality)
  • Comparator drug
D Autoimmune Evaluation of PK similarity to comparator drug
  • Antibody PK comparison
  • Healthy vs. Patient
  • Comparator drug
E Infectious Disease Population PK analyses
  • Antibody PK
  • Mixture formulation
F Infectious Disease Phase II trial design
  • Preclinical PK/PD
  • Phase I, IIa Pop PK
G Peptic Ulcer Multiple dose PK prediction
  • PK (long half-life)
  • Various loading dose scenario
H Autoimmune Phase II trial design
  • Pediatric PK
  • Orphan drug
I Autoimmune Phase II multiple dosage regimen suggestion
  • Pediatric single dose PK analysis
J Anti-cancer Phase II trial design
  • PK-PD-AE
K Autoimmune MAD design
  • PK/PD
  • Comparator drug
L Anti-cancer (mAb) MAD design
  • PK/PD

[ Pharmacometric Service Experience ]

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