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    Pharma Services Category of KAI Research

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 Compliance, Regulatory & Consulting (2)

    02 Patient / Investigator Recruitment (1)

    03 Post Marketing (1)

    04 Technology / Data / Analytics (4)

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    01 KAI Research (8)

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    01 U.S.A (8)

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    REGULATORY SERVICES

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    We support clinical sites by confirming regulatory compliance and assisting them in preparing, editing, formatting, submitting, and tracking regulatory documents such as informed consent/assent forms, HIPAA notifications, and participant information sheets.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Regulatory Affairs
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    PATIENT RECRUITMENT & CLINICAL SITE PARTNERSHIPS

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    We understand potential obstacles to recruitment and recognize the importance of a well-outlined recruitment and retention plan developed in conjunction with the study protocol.

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    Pharma Service: Clinical Trials

    Category: Patient / Investigator Recruitment

    Sub Category: Patient Recruitment
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    MONITORING FOR CLINICAL PHASES STUDIES

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    We provide standard operating procedure (SOP)–guided study monitoring, auditing, and quality assurance support for all phases and inpatient/outpatient studies at over 50 clinical sites for the biopharmaceutical industry and the National Institutes of Health.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Clinical Trial Monitoring
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    DATA MANAGEMENT & ECLINICAL SOLUTIONS

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    For each project, we develop a data management plan (DMP) that identifies the study-specific quality control steps that we will take to review the data for accuracy and completeness.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Data Management
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    STATISTICAL SUPPORT

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    Our statisticians develop statistical analysis plans, which reflect study goals and closely follow the ICH guidelines for the design of case report forms (CRFs), database structure, data plausibility checks, and quality control procedures as well as choice of study objectives, sample size calculation,

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Clinical Biostatistics and Programming
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    SAFETY & PHARMACOVIGILANCE

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    Our team of Drug Safety Associates (DSAs) provides clinical safety and pharmacovigilance support for biopharmaceuticals throughout the product life cycle.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management
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    QUALITY ASSURANCE OF TRIALS

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    Our long experience in validating clinical studies has allowed us to strengthen internal procedures to maximize accountability, systematic feedback, and quality control in all aspects of studies and data handling.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Quality & Compliance
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    OBSERVATIONAL STUDIES & REGISTRIES

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    Through our experience with large-scale domestic and international registries, we have developed innovative and cost-effective strategies to collect data. We can create accurate snapshots and document trends over time in patient clinical information and characteristics, health care services,

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Clinical Trial Monitoring
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