Clinical Research and Development Solutions

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KINETIC’s Clinical Development Team provides expert clinical study support for early phase (eg, First-in-Human/FiH, Phase 1 to Phase 2) and late-phase human clinical trials (eg, Phase 3 and Phase 4). Our study physicians and scientists collaborate with Sponsors, Principal Investigators (PIs) and medical sites and provide medical oversight for patient recruitment, safety, clinical data capture, medical monitoring, and clinical database data integrity. 

We also design and develop IND-enabling programmes including Proof-of-Concept (PoC) and FiH clinical trials.

Our experienced clinical development experts work across diverse therapy and product areas and we have specialists in oncology and immuno-oncology (IO), hematology, immunology, infectious diseases, and neurology. Additionally, KINETIC’s internal medicine specialists and clinical scientists work across all disciplines of pharmaceutical medicine with expertise in the development of innovative biologics including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), bispecific/trispecific+ antibodies, radioligands, oligonucelotides, RNA therapeutics, small molecule agonists and antagonists, CART-T cell therapies, vaccines and other innovative immunotherapeutics, gene therapies, and novel precision medicine technologies. 

Our clinical development and regulatory-associated solutions and services include: 

•  Benefit-Risk Assessments of Programs and Assets
•  Biostatistical Analysis and Review
•  Clinical Data Review and Analysis
•  Clinical Study Protocol Design
•  Clinical Study Vendor Management (Phase 1 to Phase 4) 
•  Clinical Overview Subject Matter Expertise 
•  Critical Evaluation of Lead Candidates, Clinical Programs and Portfolios
•  First-in-Human Study Design
•  Independent Medical Monitoring
•  Medical Advice and Guidance Related to Regulatory Health  Authority Interactions
• Medical Liaison and Representation with Regulatory Health Authorities (eg,  US FDA, EU EMA for Scientific Meetings)
• Medical Review of Study Narratives and Patient Profiles
• Strategic Advice and Preparation of Draft Questions and Input into Briefing  Documents with Regulatory Agencies
• Proof-of-Concept Clinical Study Design
• Medical oversight of AI-assisted and AI-generated clinical documentation

Pharmacovigilance and Safety Reporting:

•  Clinical Overview Addendum 
•  Country-Specific Periodic Reports
•  Development Safety Update Reports (DSURs)
•  Periodic Adverse Drug Experience Report (PADER)
•  Periodic Benefit-Risk Evaluation Reports (PBRERs)
•  Periodic Safety Update Reports (PSURs) 
• Risk Evaluation and Mitigation Strategy (REMS)
•  Risk Management Plan (RMP)

KINETIC’s Clinical Development Team is highly skilled and adaptive to each client's specific needs and collaborates efficiently with cross-functional groups to achieve the desired successful outcomes. Our strength lies in our expertise and streamlined processes that meet the specific requirements of our clients. 

Our collaborative clinical experts work productively to determine the scope of project requirements, identify and mitigate risks, provide solutions to challenges, and address and resolve issues to ensure project work is completed beyond expectations to support successful clinical development milestones.