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Medical & Clinical Strategy

Medical & Clinical Strategy

At CSC we understand how important your asset is to you and why failure is not an option. Before the start of a clinical trial, especially for the first time, you will be faced with some burning questions that we can help you find the answer to

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    • Medical & Clinical Strategy

      Medical Writing Capabilities across Full Clinical Development Lifecycle

    Objective

    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.

    Personnel

    We have professional experts in both China and US with knowledge of local regulations and a deep understanding of product features.

    10+ highly skilled and experienced writers with medical background.

    Capabilities

    Develop accurate, clear, and compliant documents as per the project and the regulatory requirements.

    Flexible schedule to manage and optimize document development to meet timelines.

    Industry-leading SOPs and in-depth therapeutic experience.

    Medical writing support spanning from individual documents to extensive medical writing programs.

    Complete training system to ensure constant improvement of medical team. 

    Experience

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

    Autoimmune diseases: SLE, Psoriasis, Vifiligo, RA, AD, asthma, et al.

    Metabolic disease: Diabetes, Overweight\Obesity, NASH, NAFLD, et al.

    CNS diseases: Parkinson, Alzheimer's Disease, The Guillain-Barre syndrome, et al.

    Kiss, Pain, et al.

    • With joint efforts of our clinical consulting teams and medical & pharmacology experts, we have:

      Delivered protocol designs for multi-region clinical trials (MRCT) and IND approvals in China and US, in Oncology field (solid & hematology) and autoimmune area.

      Get permission of Phase II/III Adaptive Design or single-arm design through EOP2 communication to accelerate clinical trial development.

    Work content

    IND submission: Pre-IND Communication, Protocol, CDP, IB, ICF, Clinical Overview (module 2.5), Clinical Summary (module 2.7), and RMP.

    Phase I~III study: Protocol,·IB,·CSR, SAE Narrative, Investigator Meeting, Protocol Interpretation for operation team.

    EoP2 Meeting (Communication with CDE before pivotal study): Conference Communication Request Form, Conference Communication Materials.

    NDA Submission:Pre-NDA Communication, Clinical Overview (module 2.5), Clinical Summary (module 2.7), ISS & ISE, RMP, Racial Bridging Analysis Report (Import registration).

    Phase IV study: Protocol,·CSR, Post-market Drug Safety.

    IIT study: Protocol, CSR, SAE Narrative, Investigator Meeting, Protocol Interpretation for operation team.