OUR SERVICES

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

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

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

We can serve in roles as CRO that works on deliverable basis

Work in our office and on our system that is compatible with yours
Acquire services ‘as needed’
Significantly reduce your budgeting and management efforts
Provide fast response and quickly mobilize to assist with projects behind schedule
Advanced technology and tools that are compatible with your system

We can serve in roles equivalent to your external team

Work off-site on your system or our system that is compatible with yours
Can be your team members and work as FTE on the scopes with your assignment
You have direct access/manage our FTE resources
You are welcome to play a key role in the establishment of our study team
The study lead is employed by us, but has a solid line to your manager
You may utilize our expertise and knowledge (such as expert statisticians and expert programmers) beyond the assigned team members, if it is necessary

We provide the opportunity to harmonize standards and integrate into the sponsor’s system

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