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Welcome to TigerReunion Biostatistics LLC, your expert partner in biostatistical consulting.

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Pipetting Samples

Our Expertise

At TigerReunion Biostatistics LLC, we specialize in providing expert biostatistical consulting services for pharmaceutical, healthcare, and research organizations. Our focus is on data analysis, clinical trial design, and statistical modeling to facilitate evidence-based decision-making in various fields.

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Services

Tailored Solutions

Our services are designed to meet the unique needs of each client, offering tailored solutions in data analysis, clinical trial design, and statistical modeling. We ensure that our clients have the necessary support to make informed decisions and drive successful outcomes.

BIOSTATISTICS

  • Clinical trial development plan

  • Power/sample size estimation

  • Statistical analysis plan

  • Table shells

  • Data mapping specs

  • Randomization schedule

  • Interim analysis and DMC Support

  • ISS/ISE report

  • Real world data analysis and statistical report

  • Bioinformatics services

STATISTICAL PROGRAMMING

  • Development of SDTM/ADaM

  • TFL creation and validation

  • Programming support for patient profiles and patient narratives

  • Support for CSR, ISS/ISE, Interim

  • Support to regulatory, publication

  • Support database edit checks, query

  • Support of Data Monitoring Committee

  • Data mining, support for exploratory analysis and real world data analysis

  • Prepare e-submission package

  • CDISC implementation

  • Legacy data conversion to SDTM

  • Annotating CRF pages

  • Define.pdf or Define.xml

  • Study data reviewer’s guide

  • Analysis Data reviewer’s guide

  • Submission of XPT datasets

  • Submission of programs

  • Final e-submission package

Data Management

  • Data Management Plan (DMP) creation

  • Database development

  • Data entry and cleaning

  • External data loading and reconciliation

  • SAE reconciliation

  • Dictionary coding

  • Database lock

  • EDC (Oracle Clinical)

  • EDC account management

  • EDC training and support

DATA MANAGEMENT COMMITTEE (DMC)

  • Offer full DMC Support

  • Dedicated team of both blinded and unblinded Biostatistics and Programming Support, DMS Support Statisticians and DMC Project Coordinators

  • DMC Charter development

  • DMC Statistical Analysis Plans

  • Coordination, scheduling, and attendance of DMC Data Review Meetings

  • Act as liaison between DMC and clients to preserve study and DMC integrity

  • Produce documentation (meeting agendas, open and closed reports, open and closed session minutes, DMC Recommendations, etc.) until study closeout

  • Archive all confidential, highly sensitive DMC materials in a secured, electronic repository until study closeout

  • Facilitate transfer of DMC documents to client(s)

  • Generate DMC timelines to track DMC deliverables and project milestones

REAL WORLD EVIDENCE

  • Comprehensive approach

  • Leverage real-world data (RWD) from electronic medical records (EMRs), administrative claims data, disease registries, and other health data repositories

  • Utilize databases like Flatiron, ConcertAI (Patient360 and RWD360), IQVIA Oncology EMR, Clinical Practice Research Datalink (CPRD), and Medical Data Vision (MDV)

  • Cover oncology indications like breast cancer, lung cancer, prostate cancer, gastrointestinal cancer, hematological cancer, and other non-oncology therapeutic areas

  • Global support for agencies and markets in United States, Italy, the United Kingdom, and Japan

  • External Control Arm studies (shows short-term priority evidence gaps, contextualizes long-term outcomes observed in clinical trials, and provides insights for health technology assessments and payer purposes)

  • Database studies

  • CDISC standardization

  • Implement CDISC standards for RWD to SDTM/ADaM conversion

  • Customized RWD analyses (customized treatment landscapes and in-depth biomarker)

  • Diverse range of stakeholders

MEDICAL AFFAIRS

  • Offers a diverse range of expertise and comprehensive clinical and strategic solutions

  • From initial stages of discovery through to commercialization, we provide support across all aspects of medical affairs functions

  • Our therapeutic expertise includes Immunology & Inflammation, Oncology, Ophthalmology, and Cardiovascular Disease

  • Immunology & Inflammation: Atopic Dermatitis, Asthma, Nasal Polyps, Eosinophilic Esophagitis (EoE), Chronic Obstructive Pulmonary Disease (COPD), and Rheumatoid Arthritis

  • Oncology: Lung Cancer (NSCLC), Skin Cancer (BCC & CSCC), Cervical Carcinoma, and Breast Cancer

  • Ophthalmology: Diabetic Retinopathy, Diabetic Macular Edema, and Age-related Macular Degeneration

  • Cardiovascular Disease: Recurrent Pericarditis (RP), Hyperlipidemia, and Hypercholesterolemia

  • Publication Support

  • Phase IV Registry Studies

  • Health Technology Assessments (HTA)

  • Reviewing Data Analysis for market access decision-making

  • Data mining for exploratory analysis

  • Work with Health Economics and Outcome Research (HEOR)

  • Offer support to the United States, Germany, Korea, Australia, Brazil, Canada, France, and Spain

MEDICAL WRITING

  • Protocols and amendments

  • Clinical Study Reports (CSRs) and patient safety narratives

  • Investigator brochure updates

  • Common technical document (CTD) overview and summaries

  • Integrated analyses of effectiveness (ISE) and safety (ISS)

  • Agency briefing packages

  • Informed Consent Forms (ICF)

  • Publications (abstracts, posters, manuscripts)

  • Submission-ready capabilities (electronic publishing): Fully hyperlinked and bookmarked documents

REGULATORY

  • Global Regulatory Strategies

  • Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.)

  • CMC (Chemistry, Manufacturing, Control)

  • Labeling

  • Translations of Technical Documents

  • Coordination of Regulatory Certificates

Clinical Operations and Management

  • Site Selection

  • Site Monitoring and Management

  • Project Management

  • Medical Monitoring and Safety Management

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