Medical Affairs

Our medical writing team is committed to translate complex scientific information into practical outputs with full regulatory compliance, accelerate the drug development progress by optimal clinical study design and excellent written documents, reducing the time required to bring the drug into the market.

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Medical Affairs

Risk Management is an integral part of any clinical trials.

Study Design

At CSC we believe in taking a proactive approach to the management of risks by ensuring mitigation plans are interwoven to the foundation of our study designs. Our medical affairs team has extensive experience in multidisciplinary clinical study design, works closely with each department as well as extends network to domestic consultants. Through rational methodology design to optimize the method of clinical operation, and increase success rate of clinical trials and decrease study budget effectively.
Common questions we meet during the study design:

“How do we optimize our protocol design?”

“Can we use our global protocol/CRF (case report form) in China?”

“How do we ensure our study design complies with local clinical practice?”

Beyond study design, our medical affairs team can help create other essential documents such as CRF, ICF, Patient Diaries, etc., using the same methodologies.

Clinical Study Reports (CSR)

CSC internal experts have ample experience, they can professional present study findings concise and clearly, which is an important part of any programs development. We can ensure report accuracy and uniformity while maintaining full compliance with ICH (International Council for Harmonization) and other regulatory requirements.

Medical Monitoring

Our professional medical monitors are expertise at clinical development, they strategically distribute across the domestic country, which could timely access to investigational sites and investigators.

From the perspective of clinical medicine, clinical medical information is used to participate in the development of clinical research to ensure the compliance of research and the authenticity of data.

Medical Affair Team:

All our team members are clinical medical professionals with many years of clinical work experience and rich multidisciplinary clinical experience.

Experiences:

In the last two years, we have undertaken more than 100 medical monitor services, mainly are innovative drugs, involving many fields, covering phase I-IV and BE clinical trials. Some examples are as follows:

Oncology: Immunotherapy, Monoclonal Antibodies, Targeted drug therapy et al. for solid tumor and hematology.

Rheumatic immunity: SLE, Psoriasis, Vitiligo, et al.

Metabolic diseases: Obesity, Diabetes, NASH, NAFLD, et al.

Nervous system: Optic Neuritis, Parkinson, Stroke, Alzheimer's Disease, et al.

Others: Alopecia’s, Kidney transplant, Ulcerative Colitis, Anal Fistula, Interstitial Lung Disease, Maculopathy, et al.

Our work process:

1. The beginning phase of the study: medical monitoring plan and/or research document development , training of medical knowledge related to protocol indication, etc.
2. Subjects enrollment period: medical review of research documents, medical consultation , supporting evaluation of subject eligibility, PD assessment, SAE review, medical data review in CRF, MM-onsite, etc.
3. The end of the study’s review: working document review, sorting and archiving, etc.

Medical affair department can provide you with the following services:

Regulatory Consultancy, Medical & Clinical Strategy Support

Clinical Trials Training

Medical Monitoring

Medical Writing

Protocol Design and Review (phase Ⅰ-Ⅳ)

ICF Composing

IB Design

Medical Translation

CRF Design

Trial-Specific SOP Development

Medical Writing (including CSR, medical articles, study report, etc.)

All other essential documents