Clinical Development Services

Cisema delivers clinical development services to support companies across pharma, biotech, medical devices, in vitro diagnostics (IVDs), health food, food for special medical purposes (FSMPs), supplements, and veterinary drugs. With more than 20 years of experience in China and the Asia Pacific region, we help life sciences companies bring innovative products to market efficiently and in full compliance with local regulations.

Our bilingual teams in Asia align clinical planning with regional regulatory frameworks to reduce risk, accelerate timelines, and support successful commercialization. From clinical strategy and trial design to regulatory submissions and post-market surveillance, we provide integrated support across the entire product lifecycle.

Clinical Development Services

Drug Development Strategy & Planning

We design tailored clinical development strategies aligned with product type, classification, and regional requirements. Our roadmaps integrate regulatory timelines, resource planning, and clinical milestones to support both early-stage feasibility and late-stage execution.

Our solutions include:

Integration of real-world data (RWD) and real-world evidence (RWE) into clinical development and post-market planning

Cross-functional coordination across regulatory, medical, CMC and market entry strategy

Clinical pathway evaluation for China and APAC

Regulatory submission planning embedded throughout the development lifecycle

Regulatory & Clinical GAP Analysis

Our expert team conducts in-depth assessments of clinical data and technical documentation to evaluate alignment with the target market's regulatory standards. This process identifies evidence gaps, eliminates redundancies, and enhances the likelihood of successful submissions.

Our solutions include:

Systematic review of existing clinical evidence and technical documentation

Identification of gaps based on market-specific regulatory and clinical expectations

Recommendations for supplemental data, bridging studies, or region-specific clinical trials

Strategic adjustments to accelerate regulatory approvals and reduce risk.

Expedited Approval Pathways

We guide clients through available expedited regulatory channels across China and APAC to accelerate time to market. Early engagement is critical; we assess eligibility and prepare all supporting documentation to maximize success under priority review mechanisms.

Our solutions include:

Support for Breakthrough Therapy Designation, Priority Review, and Conditional Approval Coordination of pre-submission meetings and regulatory interactions

Dossier preparation aligned with accelerated review timelines

Integration of regulatory intelligence into clinical and development strategy.

Regulatory Authority Engagement & Submission Preparation

Cisema acts as your representative in the region, managing communication with health authorities and ethics committees. We ensure that clinical submissions are accurate, compliant, and aligned with evolving regulatory requirements.

Our solutions include:

Submission-ready technical documentation (e.g. clinical trial applications, CERs, PE studies)

Health authority Q&A coordination and response management

Clinical trial oversight

Management of Clinical Trial Approval (CTA) / Investigational New Drug (IND) pathways and ethics committee submissions.

China Clinical Trials for Medical Devices & IVDs

Cisema is your go-to partner for seamless China clinical trials of medical devices and IVDs. We combine CRO-level operational precision with regulatory expertise to guide you from first concept to final NMPA approval. With deep local insight and a fully integrated approach, we help you cut timelines, boost data accuracy, and stay fully compliant every step of the way.

Our solutions include:

Strategic clinical trial planning and protocol design

Fast-track regulatory and ethics submissions

Top-tier site and investigator selection

Smooth trial execution with full safety oversight

Expert data management and statistical analysis

Comprehensive final reporting and registration submission

Hands-on support throughout the NMPA review process.

Regulatory, Scientific & Medical Writing

We develop clear, compliant, and regulator-ready documentation to support clinical and regulatory submissions across the region. Our writing services are tailored to local expectations, technical formats, and evolving standards.

Our solutions include:

Clinical summaries and study reports

Common Technical Document (CTD) modules

Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs)

Risk management files, safety narratives, and justification reports

Medical Device & IVD Post-Market Surveillance (PMS) documentation and updates.

Market Access & Commercial Strategy

Following product approval, we support your transition to commercialization by guiding pricing, reimbursement, and stakeholder engagement strategies. Our market access experts help you define and communicate your product’s value within the local healthcare landscape.

Our solutions include:

Pricing and reimbursement strategy development

National Reimbursement Drug List (NRDL) pathway insights

Value proposition refinement and health economic modeling

KOL mapping, hospital access, and distribution planning

Competitor benchmarking and market positioning.

Post-Market Clinical Support & Real World Evidence

We support the full post-approval phase, helping you maintain regulatory compliance and generate robust evidence to demonstrate product performance, safety, and potential for label expansion.

Our solutions include:

Compliance monitoring under China’s MAH system and APAC-specific requirements.

Medical Device & IVD PMS report generation, PSURs, and signal detection

Phase IV and post-market clinical follow-up (PMCF) planning

Real world evidence (RWE) study design and implementation

Therapeutic Area & Product-Specific Expertise

Biotech & Advanced Therapies

We support strategic clinical planning and regulatory alignment, among others, for antibody-drug conjugate (ADC), gene therapies, cell-based products, and biologics. Our expertise spans early-phase feasibility through market authorization, ensuring compliance with APAC regulatory frameworks.

Pharmaceuticals

We guide pharmaceutical companies through every stage of the product lifecycle, from early development to market access. We deliver targeted regulatory strategy, CTA and IND preparation, gap analysis, and submission-ready documentation. Our team supports local study design, leverages expedited approval pathways, and drives market success through pricing insights, stakeholder engagement, and competitive intelligence.

Veterinary Drugs

We provide guidance for the clinical development of veterinary pharmaceuticals and health products, including study design, documentation, and regulatory submission for animal health authorities.

Medical Devices

We prepare Clinical Evaluation Reports (CERs), develop localized clinical trial strategies, and manage post-market surveillance for Class II and III devices, including high-risk implants and digital health technologies.

In Vitro Diagnostics (IVDs)

We deliver performance evaluation strategies aligned with regulatory expectations for IVDs and companion diagnostics, including clinical validation, analytical studies, and post-market performance evaluations.

Health Food, Food for Special Medical Purposes (FSMP), & Supplements

Our services include human clinical study design to substantiate functional claims and nutritional value, aligned with Chinese and regional health food regulations.