Clinical Operations at GCP ClinPlus: Expert Trial Execution Across China

At GCP ClinPlus, our Clinical Operations team serves as the cornerstone of our full-service CRO offerings, providing end-to-end clinical trial management with precision, speed, and regulatory excellence. With over 2,000 clinical projects completed and 200 NDA approvals—including 4 FDA/EMA approvals—we are a trusted partner for sponsors seeking to navigate China's dynamic clinical research landscape.

Comprehensive Clinical Trial Management

Our Clinical Operations services encompass every phase of trial execution:

●Site Feasibility & Selection: Leveraging our network of over 1,400 GCP-compliant research sites across China, we identify and initiate high-performing sites tailored to your study needs.

●Study Start-Up (SSU): Efficiently managing center screening, regulatory submissions, and site initiation to accelerate trial commencement.

●Patient Enrollment & Retention: Implementing strategies to optimize patient recruitment and maintain engagement throughout the study.

●Clinical Monitoring: Conducting regular site visits and remote monitoring to ensure protocol adherence, data integrity, and patient safety.

●Data Management Support: Collaborating closely with our data management team to facilitate timely data cleaning and query resolution.

Site Management & Close-Out: Overseeing site operations to ensure compliance and managing the close-out process efficiently.

Our project teams are strategically located in over 30 major cities across China, enabling rapid response to project needs and efficient execution of study timelines. This extensive geographic coverage allows us to effectively manage multicenter trials and address region-specific challenges.

Experienced Project Leadership

Our PD team averages over 16 years of industry experience and our PM team averages over 10 years of industry experience, bringing deep therapeutic knowledge and operational expertise to each study. Project Directors are actively involved from proposal development through to the final data analysis, ensuring consistent oversight and proactive risk management throughout the trial lifecycle.

Our focused expertise in these areas enables us to anticipate challenges and implement effective solutions tailored to each therapeutic domain.

Strategic Advantages of Partnering with GCP ClinPlus

●Access to Treatment-Naïve Populations: Facilitating enrollment by tapping into China's vast patient pool.

●Regulatory Expertise: Navigating NMPA's accelerated approval pathways with proven success.

●Cost Efficiency: Delivering high-quality services at 30–40% lower costs compared to US/Europe.

●Expedited Timelines: Achieving faster patient recruitment and study completion.

By integrating local insights with global standards, GCP ClinPlus ensures that your clinical trials in China are conducted with the highest levels of quality, compliance, and efficiency.

Nationwide Presence, Local Expertise

Therapeutic Specialization

●At GCP ClinPlus, we pride ourselves on our extensive experience and proven success in managing clinical trials across a diverse range of therapeutic areas. Our dedicated teams and strategic partnerships enable us to deliver high-quality, efficient, and compliant clinical research solutions tailored to each therapeutic domain.

Oncology

With a robust portfolio of 500+ oncology clinical trials, GCP ClinPlus has established itself as a leader in cancer research, collaborating with 80% of oncology specialty hospitals in China. Our comprehensive services span early-phase studies to pivotal trials, supporting the development of innovative oncology therapies.

Endocrinology &

 Metabolic Diseases

As a founding member of the China Diabetes and Metabolic Diseases Clinical Trial Consortium, we have cultivated strong collaborations with key opinion leaders and leading hospitals in this field. Our involvement ensures access to specialized expertise and patient populations essential for successful endocrinology and metabolic disease trials.

CGT    

Recognized as a top clinical partner for cell and gene therapy (CGT) companies in China, GCP ClinPlus offers specialized support for these complex trials. Our experience encompasses regulatory navigation, site selection, and patient recruitment, facilitating the advancement of cutting-edge CGT therapies.

Rare Diseases

Our commitment to rare disease research is demonstrated through our support of clinical trials involving small molecules, gene/cell therapies, and RNA-based drugs. We have contributed to the approval of several rare disease treatments, addressing unmet medical needs in this challenging area.

Ophthalmology

GCP ClinPlus has extensive experience in ophthalmology, having managed over 60 clinical research projects in this domain. Our collaborations include partnerships with internationally renowned companies such as Bausch + Lomb and Santen, as well as emerging biotech firms, covering a spectrum of ophthalmic indications.en.gcp-clinplus.com

Autoimmune Disorders

With a strong medical team averaging over 10 years of physician experience, we have supported more than 13 clinical trials in autoimmune diseases. Our expertise ensures rigorous study design and execution, contributing to the development of effective autoimmune therapies.

Dermatology

Our dermatology portfolio includes over 20 studies ranging from investigator-initiated trials and first-in-human studies to pivotal phase III trials. This breadth of experience underscores our capability to manage dermatological research across various stages of development.

Medical device

Orthopedics, ophthalmology, neurology, exology, digestion, cardiology, nephrology, etc

Additional Therapeutic Areas

Beyond the aforementioned specialties, GCP ClinPlus has also conducted clinical trials in respiratory diseases, infectious diseases, vaccines, and medical devices. Our versatile experience enables us to adapt to the unique requirements of each therapeutic area, ensuring successful trial outcomes.