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Clinical | Japan Market Entry / Blog

Rare Disease Day, observed on the last day of February […]

CDMO | Clinical | Consulting | CSO | Healthcare | Japan Market Entry | Non-Clinical / Brochures

The first and largest CRO in Japan offers you services […]

CDMO | Clinical | Consulting | CSO | Healthcare | Japan Market Entry | Non-Clinical / Brochures

CMIC Group Overview, as of December 2023. Corporate Overview History […]

Healthcare | Japan Market Entry / Blog

As we step into 2024, the healthcare industry is undergoing […]

Clinical | Japan Market Entry / Featured Articles

Japan’s clinical trial landscape has vastly expanded over the last […]

Clinical / White Papers

ICH M10 is the first-ever global set of guidelines for […]

CDMO / Brochures

Your Strategic Partner for Expert Drug Development and Manufacturing Fully […]

Clinical / Blog

The Asia-Pacific (APAC) region has continued to  thrive as a […]

Clinical / White Papers

Fallout from the COVID-19 pandemic, global unrest, and more are […]

Clinical / Featured Articles / White Papers

Recent advances in genetic analytic technologies like next generation sequencing […]

Clinical / Video

Keiko Oishi, President and COO, CMIC HOLDINGS Co., Ltd. talks […]

Clinical | Japan Market Entry / C-CAST / Video

Listen to our expert talk about the latest market environment […]

Clinical | Japan Market Entry / White Papers

Japan represents an attractive and largely untapped market for each […]

Healthcare / C-CAST

C-CAST is a mini-video series presented by CMIC Group. As […]

/ Featured Articles

Fumiaki Koizumi President, Mercari, Inc. President/CEO, Kashima Antlers F.C. Co., […]

/ C-PRESS

C-PRESS is a Public Relations Magazine from CMIC Group. It […]

Non-Clinical / White Papers

As pressures increase to get drugs to market faster, developers […]

CDMO | Clinical | Consulting | CSO | Healthcare | Japan Market Entry | Non-Clinical / Brochures

We sincerely appreciate your support during our 30 year journey!​ […]

Clinical | Consulting / Brochures

Our team has an average of 10+ years of oncology […]

/ Featured Articles

Yusuke Akamatsu Digital Finger Painter Born in Ibaraki, Osaka on […]

/ C-PRESS

C-PRESS is a Public Relations Magazine from CMIC Group. It […]

Clinical / White Papers

The industry is turning towards real-world data to create more […]

Clinical / White Papers

Rare diseases have smaller patient populations, which make drug development […]

Clinical / Blog

This year marked the return of The Summit for Clinical […]

Consulting / Webinars

When utilizing RWD, the selection of the medical information database […]

Consulting / Brochures

CMIC provides high quality services in accordance with your request, […]

Clinical / White Papers

The Latest Insights into Clinical Studies in Japan The Pharma […]

/ Featured Articles

Terumasa Hino Jazz Trumpeter Born in Tokyo on October 25, […]

/ C-PRESS

C-PRESS is a Public Relations Magazine from CMIC Group. It […]

Clinical / Brochures

Considering improvement of patients’ QOL with high-quality digitalized treatment support […]

CDMO | Clinical | Consulting | CSO | Healthcare | Japan Market Entry | Non-Clinical / Featured Articles

This is the article originally published in Newsweek on November […]

CDMO / C-CAST

C-CAST is a mini-video series presented by CMIC Group. As […]

Healthcare / Blog

Japan has spent the last year and a half battling […]

/ Featured Articles

Yasumasa Yamamoto U.S. venture capitalist Specially Appointed Associate Professor, Graduate […]

/ C-PRESS

C-PRESS is a Public Relations Magazine from CMIC Group. It […]

CDMO / Blog

Since its introduction in the 1980s, the market of orally […]

Clinical | Consulting / C-CAST

This C-CAST covers: Regulatory Framework for Cell and Gene Therapy […]

Japan Market Entry / Webinars

10 years ago, CMIC, the leading CRO in Japan, and […]

Clinical | Japan Market Entry / White Papers

Expanding to Asia can be a logical next step for […]

Clinical | Healthcare / White Papers

Digital therapeutics (DTx) are evolving rapidly. Many now provide drug-like […]

/ Featured Articles

  Nobuko Nakano Brain Scientist Kazuo Nakamura Chairman and CEO, […]

/ C-PRESS

C-PRESS is a Public Relations Magazine from CMIC Group. It is […]

CDMO | Clinical / Webinars

The COVID-19 global pandemic took the world by storm, disrupting […]

Japan Market Entry / Blog

On March 10, 2021, CMIC Group in collaboration with RDD […]

Clinical / Blog

Clinical drug development is a costly process that takes 10 […]

Japan Market Entry / Video

CMIC provides full pharmaceutical capabilities for overseas business partners to […]

CDMO / White Papers

Virtual pharmaceutical companies often have strong regulatory and clinical teams, […]

/ Featured Articles

Takao Doi Astronaut Graduate School of Advanced Integrated Studies in […]

Clinical / White Papers

As of December 2020, after the first wave of the […]

Non-Clinical / C-CAST

This C-Cast covers solutions for current and upcoming PK/PD needs […]

/ C-PRESS

C-PRESS is a Public Relations Magazine from CMIC Group. It […]

/ Video

CMIC recently presented the keynote at Proventa Oncology Strategy Meeting […]

CDMO / C-CAST / Video

Executive interview with CMIC CDMO CEO, Makoto Matsukawa Interview Includes: […]

/ C-CAST / Video

Executive interview with CMIC Group’s COO, Keiko Oishi Interview Includes: […]

/ C-CAST / Video

Executive interview with CMIC Group’s CEO & Founder, Kazuo Nakamura […]

/ Featured Articles

Naoto Ishida Representative, Urawa Digital Planning, LLC Kazuo Nakamura Chairman […]

Japan Market Entry / White Papers

New Pharma Opportunities And Market Access Challenges In Japan  Download […]

Clinical | Consulting | Japan Market Entry / Webinars

Japan and China are the 2nd and 3rd largest pharmaceutical market with […]

Clinical / C-CAST / Video

C-CAST is a mini-video series presented by CMIC Group. As […]

Clinical | Consulting | Japan Market Entry / C-CAST / Video

C-CAST is a mini-video series presented by CMIC Group. As […]

Consulting | Japan Market Entry / C-CAST / Video

C-CAST is a mini-video series presented by CMIC Group. As […]

CDMO / Video

Learn more about CMIC Group’s parenteral drug manufacturing building of […]

Clinical | Non-Clinical / Webinars

Before COVID-19 vaccine development, mRNA therapeutics has already become a […]

Clinical | Non-Clinical / Video

CMIC’s Chicago, Illinois location is a global CRO with over […]

CDMO / Video

Your Strategic Partner for Expert Drug Development and Manufacturing  As […]

CDMO / White Papers

Development and Manufacturing: Insights into the Precision Medicine Model  Download […]

Clinical | Non-Clinical / Webinars

In recent years, attempts to utilize messenger RNA (mRNA) for […]

Clinical | Non-Clinical / White Papers

[CMIC Group Whitepaper] For decades, analytical testing has played a […]

CDMO | Clinical | Consulting | CSO | Healthcare | Japan Market Entry | Non-Clinical / Video

CMIC was founded in 1992 as the first contract research […]

Clinical / White Papers

The story of CMIC’s rise from being a startup in […]

Clinical / Webinars

In March 2020, at the height of the COVID-19 outbreak, […]

CDMO / eBook

April 2020, Pharmaceutical Technology Download this eBook to learn more […]

/ C-PRESS

C-PRESS is a Public Relations Magazine from CMIC Group. It […]

/ Featured Articles

Takeshi Karasawa Former Director-General for Regional Revitalization, Headquarters for Overcoming […]

Clinical / eBook

Common Thread in Recent Regulatory & Policy Discussions Considerations When […]

Clinical / Webinars

The Asia-Pacific (APAC) clinical trials market reached approximately US$3.8 billion […]

Japan Market Entry / Webinars

The world rare disease market has grown and it’s projected […]

Clinical / Brochures

Tailor our early phase clinical trial platform to meet your […]

Clinical / Brochures

Supporting your drug development journey with strong Asia presence In […]

Clinical | Consulting / Brochures

One-stop solutions for the world’s largest markets As the largest […]

Clinical | Consulting / Brochures

End-to-End Solutions for Cell & Gene Therapy / Regenerative Medicine […]

CDMO / Brochures

Your Strategic Partner for Expert Drug Development and Manufacturing Bridging […]

Japan Market Entry / Brochures

Tailor our services to meet your Japanese market entry needs […]

Clinical | Consulting | Non-Clinical / Webinars

The global regenerative medicine market was valued at USD 23.8 […]

/ C-PRESS

C-PRESS is a Public Relations Magazine from CMIC Group. It […]

Clinical | Non-Clinical / White Papers

Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA) and 5th GCC (14 November 2011, Barcelona, Spain) Closed Forums. These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.

Clinical | Non-Clinical / White Papers

The 2nd Global CRO Council (GCC) for Bioanalysis Closed Forum was held on 15 April, 2011 in Montreal, Canada. In attendance were 45 senior-level representatives from 39 CROs on behalf of eight countries.

Clinical | Non-Clinical / White Papers

The topic of Incurred Sample Stability (ISS) has generated considerable discussion within the bioanalytical community in recent years.  The subject was an integral part of the 7th Annual Workshop on Recent Issues of Bioanalysis (WRIB) held in Long Beach, California, USA, in April 2013, and at the Global CRO Council (GCC) meeting preceding it.  

Clinical | Non-Clinical / White Papers

An Open Letter written by the GCC describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings lead to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past two years.

Clinical | Non-Clinical / Scientific Publications

Microdosing has been used as an investigative pharmacokinetic tool for approximately 10 years. Initial skepticism of the value of these studies was followed by investigative clinical trials to understand the circumstances when they provide useful data and this has led to routine use. When first introduced, accelerator mass spectrometry coupled with LC fractionation (LC+AMS) was the only technology that could provide the sensitivity required for these studies. Over the years, LC-MS/MS sensitivity has improved so that it is now viable to use this technique for microdosing studies, and a decision needs to be made on what technique to use.

Clinical | Non-Clinical / Scientific Publications

Traditionally, absolute bioavailability ( has been determined using a crossover study design, requiring administration of an IV dose expected to give plasma concentrations similar to those arising from the therapeutic extravascular (EV) dose. An alternative approach is to administer an isotopically labelled IV microtracer dose concomitantly with the EV dose (see Figure 1 This methodology is both scientifically superior and more resource efficient With the inclusion of ABA data mandatory for marketing applications submitted to the Australian TGA 1 and other regulators increasingly asking for this information, a growing number of such studies are being conducted

Clinical | Non-Clinical / Scientific Publications

Arachidonic acid metabolites are biologically active lipid molecules that regulate many functions and play critical roles in a variety of physiological and pathophysiological processes. Some of the eicosanoids are used as a potential biomarkers related to inflammation, immune reactions and side-effects of drugs. Eicosanoids are derived from arachidonic acid and then from other metabolites by enzymatic and non-enzymatic reactions and have very similar structure and physical properties. Pattern of intermediates and final eicosanoids production is determined in a stimulus and cell-specific fashion. Fast and simultaneous qualitative and quantitative profiling of eicosanoids (lipidomics) in biological samples is possible because of high sensitivity and selectivity of liquid chromatography/mass spectrometry methods and simplicity of sample preparation.

Clinical | Non-Clinical / Scientific Publications

5-Fluorouracil (5-FU) is well-known anti-cancer drug,widely used for decades against a variety of solid tumors. 5 -Fluorouracil has a narrow therapeutic index, there is a very little difference between the theoretical minimum effective dose and the maximum tolerated dose, and therefore it needs to be administrated intravenously to control therapeutic dosage.

Clinical / Scientific Publications

A sample treatment procedure and high-sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for quantitative determination of nicardipine in human plasma were developed for a microdose clinical trail with nicardipine, a non-radioisotope labeled drug.

Clinical | Non-Clinical / Scientific Publications

The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before the start of the 6th Workshop on Recent Issues in Bioanalysis.

Clinical | Non-Clinical / Scientific Publications

The importance of appropriate sample management in regulated bioanalysis is undeniable for clinical and non-clinical study support due to the fact that if the samples are compromised at any stage prior to analysis, the study results may be affected. Health authority regulations do not contain specific guidance on sample management; therefore, as part of the Global Bioanalysis Consortium (GBC), the A5 team was established to discuss sample management requirements and to put forward recommendations.

Clinical | Non-Clinical / Webinars

In recent years, the large molecule drug development market continues to lead the way with double digit growth, driven by various factors such as increase in elderly population, surge in prevalence of chronic diseases such as cancer and diabetes, and the rise in strategic collaborations and funding in the biopharmaceutical industry. Alongside large molecule drug development, oligonucleotide therapeutics is also emerging as an established and validated class of drugs that can modulate a multitude of genetic targets. Since 2016, five oligonucleotides have been approved to treat a range of diseases.

Clinical / eBook

The clinical development phase continues to represent the most challenging stage of drug development globally, critical to the successful commercialization of new products but posing multiple and complex considerations in terms of trial design, enrollment and outcomes. Failure can prove costly and even critical to the survival of smaller companies heavily reliant on relatively few pipeline assets.

Clinical / White Papers

The contract research organization (CRO) market in the Asia-Pacific (APAC) region is the fastest- growing in the world, with revenue expected to increase at a 20% compound annual growth rate (CAGR) from 2016 to 2021 compared with the rest of the world’s 11.4% CAGR.

Clinical / White Papers

There is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. With a more receptive climate for both starting and running trials, an improved infrastructure for clinical research, and significant advances in accelerating drug approvals, Japan is now firmly on the global development map.

CDMO / eBook

Contract manufacturers are right at the center of the transformation that is reshaping the pharmaceutical and biotech industry. Their central position brings opportunities and challenges that keep them striving to stay on top of quality, technological innovation and safety and regulatory considerations. The flip side of this is working strategically to ensure the right business decisions are made, managing costs and astutely investing in technology.

CDMO / Webinars

Since its introduction in the 1980s, the market of orally disintegrating tablet (ODT) has grown annually and ODTs are now available in a variety of therapeutic areas, both over-the-counter (OTC) and by prescription. ODT market is projected to reach US$21B in 2023. In this webinar, CMIC and Aprecia experts talked about advanced ODT technologies and its advantages in drug development.

Clinical / Webinars

The webinar was presented by experts in CMIC Group, focusing on tips and insights for early phase oncology drug development in Asia: the market trend, development strategy, regulatory requirements and a case study with step-by-step planning to ensure clinical trial success.

Clinical | Consulting | Japan Market Entry / Webinars

The webinar focused on an overview of the Japanese pharmaceutical market, its unique characteristics, regulatory updates and market entry options. Through a case study, our industry experts provided step-by-step guidance on what to look out for and to how to ensure a successful market entry.

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