Data Management Services

  • Manage in-house and out-sourced data management activities for ongoing clinical trials
  • Create and/or review data management documentation, including but not limited to, data management plans, data handling guidelines, data quality review plans, CRF completion guidelines, annotated CRFs, data transfer agreements, external data reconciliations, and database quality control/audit plans
  • Develop and/or review Standard Operating Procedures for in-house and out-sourced data management
  • Participate in vendor evaluations and qualifications
  • Drive CRF development in accordance with CDASH standards
  • Oversee successful database development and execute database UAT
  • Clean and lock data in support of interim analyses and submissions
  • Provide CDASH, CDISC, 21 CFR Part 11, and GCDMP data management expertise
  • Medical Coding - MedDRA and WHO Drug
  • Rescue Studies

Clinical Data Management Database Expertise

  • Medidata Rave┬«
  • Oracle InFormTM
  • DATATRAK ONETM
  • Medrio
  • Clinical Studio
  • Bioclinica Express
  • iDataFax┬«
  • IBM Clinical Development
  • ClinCapture

Indication Experience

  • Acne
  • Acute Kidney Injury
  • Advanced Solid Tumors
  • Advanced Solid Tumor Malignancies
  • Allergic Conjunctivitis Associated with Nasal Allergy Symptoms
  • Anaplastic Gliomas
  • Asthma
  • Bladder Cancer
  • Breast Cancer
  • Breast Implants
  • Chemotherapy-Induced Neutropenia (CIN)
  • Chronic Myeloid Leukemia
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Colorectal Cancer
  • Cystic Fibrosis
  • Dementia Alzheimer's Type
  • Dravet Syndrome
  • Eosinophilic Esophagitis
  • Extensive Stage Small Cell Lung Cancer
  • GNE myopathy
  • Headache
  • Hematologic Malignancies
  • High Grade Glioma
  • Human Abuse Liability
  • Hypertension
  • Idiopathic Pulmonary Fibrosis
  • Lennox-Gastaut Syndrome
  • Lymphoid Malignancies
  • Malignant Melanoma
  • Metastatic Melanoma
  • Migraine with Aura
  • Mucopolysaccharidosis (MPS) VII
  • Multiple Myeloma
  • Non-Small Cell Lung Cancer
  • Nontuberculosis Mycobacterial (NTM) Lung Infections
  • Onychomycosis
  • Opioid-Induced Constipation
  • Oral Mucositis
  • Ovarian Cancer
  • Pain and Anxiety Before, During and After an Elective Abdominal Liposuction Procedure
  • Post Herpetic Neuralgia (PHN)
  • Post-Op Pain Management for Major Abdominal Surgery and Unilateral Total Knee Replacement
  • Post-Operative Nausea and Vomiting
  • Psoriasis
  • Schizophrenia
  • Sedation
  • Sickle Cell
  • Surgical Wounds
  • Trauma

IT Vendor Auditing/Process Support Services

  • Lead vendor evaluations and qualifications on behalf of clients
  • Ensure GCP compliance from an IT perspective
  • Offer process improvement strategies, using best practice from frameworks such as Information Technology Information Library (ITIL)
  • Execute validation for commercial off the shelf software and proprietary software per 21 CRF Part 11
  • Develop and/or review Standard Operating Procedures for in-house and out-sourced IT
  • Manage the performance of vendors using metrics and KPIs that conform with contractual agreements