Dr. Henry Wu is the Chief Executive Officer of CR Medicon, a full service clinical CRO in China dedicated to providing high-quality clinical trial management services for the biopharmaceutical industry.
CR Medicon is one of China’s most well-known clinical CROs. Their core team is a group of experts from CROs and pharmaceutical companies that are highly experienced with domestic and global clinical trials. At present, they have more than 560 full-time employees globally and their leadership team has on average 15+ years of professional experience.
This conversation with Dr. Henry Wu will provide an overview of the clinical research landscape in China. Is China an interesting country for clinical trials? What are the advantages? How can CR Medicon help biotech companies planning clinical studies in China? Let’s talk about it.
Patricio Ledesma (PL): Ni hao Henry. I appreciate your availability to talk to us about conducting clinical trials in China.
Henry Wu (HW): Thank you for having me, Patricio!
PL: Could you explain a little bit your professional background, field of expertise, and role at CR Medicon?
HW: I am a statistician by training. I have been in the pharmaceutical industry for more than 20 years.
PL: How has the clinical research industry evolved in China in the last years?
HW: Over the past 10 years, the Chinese Government, academic organizations, and biopharmaceutical companies have tried to transition the nation from a consumer of generic drugs into a developer of innovative therapies. China’s CRO market value is anticipated to reach US$27.04 billion in 2024, growing at a CAGR of 27.06%, for the period spanning from 2020 to 2024 [1].
PL: Why should U.S. or European sponsors consider executing clinical trials in China? What are the particular advantages?
HW: China now strives to be at the forefront of clinical research and drug development. There are many advantages to conducting clinical trials in China including huge patient populations, a large and growing network of hospitals qualified to conduct high standard clinical trials, skilled clinical trial and laboratory professionals and project leaders, strong support from the government for international partnerships, improved regulatory environment for clinical trials and new drug approval, and strong enthusiasm for international collaborations.
PL: What are the main cities in China where more clinical trials are performed?
HW: There are many hospitals capable of conducting clinical trials, these traditionally include teaching hospitals in major first-line cities such as Beijing and Shanghai. With recent changes of regulations, a lot more hospitals are now available for GCP compliance clinical trials in most major cities in China.
PL: What services can CR Medicon offer to biotech and pharma companies planning clinical studies in China?
HW: CR Medicon provides full clinical trial services in China. For foreign companies coming to China, our services start from initial consultation of the clinical development plan with our US based colleagues. Our regulatory affair colleagues will guide the process making sure the best registration path is in place. Our medical and clinical operations teams help clients partner with KOLs along with suitable sites and implement trials in the field. Our project managers frequently communicate with sponsors reporting progress of the trials and discuss further steps.
PL: China is a big country. How do you ensure high quality clinical operations in such a large territory?
HW: CR Medicon is one of the biggest CROs in China with employees in most major cities, and our trial sites are managed by local colleagues who are well trained and highly experienced in conducting/managing trials.
PL: How long does it take to have a clinical trial approved in China? How many months from submissions to authorities until recruitment initiation?
HW: Clinical trial approval process in China has been shortened dramatically with recent regulatory reform with NMPA. IND Review timelines have been reduced to 60 working days and the processes have been simplified. If no queries are raised by CDE (Center of Drug Evaluation), the IND application is considered to be approved.
PL: Is China a particularly interesting country to do clinical research in some types of diseases?
HW: China is a country with vast populations, providing a large number of patient resources, which makes China suitable for trials in most disease areas with very fast patient enrollment. Diseases more prominent in China include gastrointestinal tumors, hepatitis B, et al. These are still hugely unmet medical needs representing great commercial opportunities.
PL: In what therapeutic areas is CR Medicon strong?
HW: CR Medicon has ample experience in most therapeutic areas. In particular, we have had large number of oncology trials conducted in all phases.
PL: Do you also provide CRO services in the United States?
HW: CR Medicon has its US subsidiary based in New Jersey. We mainly provide clinical trial data management and biometrics services in US. We also have strategic partnerships with the Maryland-based Pharmaron clinical pharmacology center, providing Phase I clinical trials of both healthy volunteers and cancer patients.
PL: I was able to see that CR Medicon has solid capabilities in clinical data management and statistical programming. Could you give more details about these two service areas?
HW: Thank you for mentioning the data management and biometrics services. I have led both functions from the incorporation of CR Medicon, now we have more than 260 full time employees serving international clients. These two functions are the core competencies of CR Medicon, led by experienced pharma veteran biostatisticians and programmers.
PL: What are your practical recommendations to ensure high-quality data in a clinical trial?
HW: Optimized process and quality systems are the guiding principle to ensure data quality. Using globally recognized IT system is the key to achieving international data quality. A large percentage of our services were conducted using top systems such as Medidata Rave for EDC and Oracle Argus for pharmacovigilance.
PL: Do you have biological sample analysis capabilities?
HW: Yes, we have an in-house bioanalytical department working on trials sample analysis. It is a newly built facility with state-of-the-art instrumentation and management system.
PL: Generally speaking, what is your top advice to biotech companies getting ready for their early phase clinical trials? What aspects are important when planning phase 1 clinical studies?
HW: A solid development strategy is the start of every clinical program. The outcome for Phase I trials should provide solid rationale for subsequent researches. Phase I studies are also a great start to engage the sites and KOLs. Careful KOL selection, site selection, and quality execution of Phase I trials lay the foundation for the success of a clinical trial program.
PL: What is your counsel to biotech companies planning large phase 3 international trials? How can biotechs handle the operational complexities of multinational pivotal studies?
HW: This is a very big topic and every Phase 3 MRCT is unique in some way. Phase 3 MRCT is certainly much more complicated than a regional Phase 3. Consideration of clinical practice, patient population, and regulatory guidelines of each participating country will definitely be needed.
PL: Henry, thanks so much for this interview. It was very nice to talk to you.
HW: My pleasure Patricio, thank you for having me.
About CR Medicon
CR Medicon Pharmaceutical Technology Co., Ltd., a controlling subsidiary of Pharmaron, is a fast-growing Contract Research Organization (CRO) providing customers with one-stop clinical development services for pharmaceutical, biotech and medical device companies.
CR Medicon’s services include Regulatory Affairs, Medical Strategy, Medical Writing, Medical Monitoring, Pharmacovigilance, Clinical Operations, Data Management, Statistical Analysis and Bioanalytical Laboratory.
CR Medicon is headquartered in Nanjing, China, with 16 service branches nationwide and 6 sites in China and in the U.S. We currently have more than 550 full-time employees worldwide and our management team consists of experts with more than 15 years of industry experience.
CR Medicon has provided high-quality clinical development services to more than 200 industry clients worldwide.
For further information about conducting clinical trials in China, please contact us at info@sofpromed.com
References:
- https://www.globenewswire.com/news-release/2020/04/23/2020657/0/en/China-Contract-Research-Organization-CRO-Market-Insights-2020-2024-Clinical-Pre-clinical-and-Discovery.html
