Capabilities
- Case Report Form (CRF) Development
- Database Design
- Statistical Programming
- Data Quality Validation
- Query Management
- Data Entry Systems Development
- Duel Key Data Entry
- Creation of SAS Analysis Datasets
- Data Management Plan Development
- SOP Development
- Medical Coding
- Quality Control and Assurance
- Status Reports
Statistical Consulting
- Study Design, Sample Size Estimation, Randomization
- Protocol Development
- Clinical Program Development
Statistical Analysis
- Study Design
- Statistical Analysis Plans
- Tabulation Mock-ups
- Programming and Analysis Specifications
- SAS Programming
- Analysis Dataset Creation
- Report Tables, Listings, Figures
Data Safety Monitoring Board
- Charter Preparation
- Statistical Representation
- Interim Analysis
- Group Sequential Design
- Reporting
Quality Assurance
- Preparation of Essential Document Review Guidelines
- SOP Development
- Compliance and Auditing Services
- Good Laboratory Practice Audits
- Protocol Review
General
- Proof of Principle Study
- Pilot/Feasibility Study
- Poster Presentation
- Slide Presentation
- Manuscript Preparation
- Manuscript Review
- Literature Review
- Statistical Methods Review
- SOP Development
- Regulatory Support
- FDA Preparation, Consultation and Meeting Attendance
- Electronic Data Capture (EDC)
- Data Capture, Transformation, Integration, Migration
- Legacy Data Conversion
- Regulatory-Compliant Data Structures (e.g. CDISC, CDASH, SDTM, ADAM)
- Secure Publishing
All statistical software is licensed, and includes:
Statistical Software
- SAS (SAS Institute, Cary, NC) –TS Level 2M3 on XP_PRO platform
- SigmaPlot
- DBMS/COPY
- nQuery Advisor
- PASS
- EAST
- StaTable, Cytel, Inc.
- StatXact 6
- LogXact
- JMP
Medical Coding Dictionaries
- MedDRA
- WHO-Drug Coding Dictionary
Text Editing
- Ultra Edit
- Ultra Compare Professional
- SAP Maker
- SAP Content
- Adobe Reader
- Microsoft Office
Computer Backup and Security
- Malwarebytes Anti-Malware
- Avira AntiVir
- NovaBACKUP
- RAID Computer Architecture
Data Transfer
- FTP Server for Electronic Data Transfer
- FileZilla Client
Therapeutic Areas
Allergy and Respiratory
- Chronic Bronchitis
- Asthma
- General Respiratory Disorders
Oncology
- Liver Cancer
- Lung Cancer
- Skin Malignancies
- Breast Cancer
- Colorectal Cancer
- General Oncology
- Palliative Care
- Brachytherapy/radiation Therapy for Inoperable Liver Cancer
Cardiovascular
- Stents
- Pulmonary Arterial Hypertension
- General Cardiovascular
- Pulmonary Hypertension
- Scleroderma
- Interstitial Lung Disease
- Arterial Hypertension
Metabolism & Endocrinology
- Dyslipidemia
- Obesity
- Weight Loss
- Bone Growth
- Diabetes Complications
- General Metabolism and Endocrinology
- HPA Axis Investigation / Erythropoitin
Musculoskeletal
- Osteoporosis
- General Musculoskeletal
Gasteroenterology
- Abdominal Pain
- Irritable Bowel Syndrome
- Food and Nutrition
- Gastrointestinal Reflux Disease
- General Gastroenterology
Genitourinary, Gynecology, Women’s Health
- Urinary Incontinence
- Contraception
- Contraceptive Gel
- Uterine Fibroid Treatment
Infectious Disease & Immunology
- AIDS / HIV
- Otitis Media
- Transplantation Steroid Sparing
- Transplantation HLA Donor Compatibility Testing
- General immunology
- General infectious disease
- Opthamology
- Cataract Correction
- Intraocular Lens
- General Opthamology
- Immunoglobulins
Dermatology
- Acne
- Photodamage
- Cosmetic Dermatology
- Wound Healing
- Wrinkles
- Pigmented Lesions
- General Dermatology
Hematology
Neurology, Psychology, Anesthesiology
- Drug Abuse
- CNS Infections
- Seizure Disorders
Other
- Quality of Life Instruments
- Pharmaco-Economic Reimbursement Studies
- Transplantation
- Anti-Rejection Drugs
- HLA Donor Matching
- Assay Development
- Drugs of Abuse Testing
- HIV-1 ELISA
- P24 Antigen
- T-cell Signal Transduction Pathways
- Tumor Markers
- HLA Donor Compatibility Testing
- SPECT/CT vs PET/CT Lung Cancer Detection
- Ittrium-90 Treatment In Liver Cancer
- MR Guided Focused Ultrasound Ablation Uterine Fibroids
- Cardiac Rerfusion MRI
- Breast Imaging
