"Summary level clinical trial outcomes databases collect and consolidate valuable information published in the medical literature in a controlled and standardized fashion that can be efficiently used to support meta-analysis based modeling and simulation activities for key decision making at various phases of drug development."

Clinical Trial Outcome Database (CTOD) is offered both as Products and Services

Products

Excelra in collaboration with Quantitative solutions (QS) develops and markets a suit of clinical trial outcomes databases that are available "off the shelf" with a definitive scope and can be further supported by customization and M&S consulting by Excelra and QS respectively.

Custom Development Service

We also develop Clinical databases that support MBMA on custom basis with a focused scope and clinical literature in a client desired data structure that facilitates quick data analysis.

Salient Features

Database Model and Process: Comprehensive and scalable data structure

  • Adaptable for multiple indications
  • Allows easy expansion to newer treatments, endpoints, and trials (from both public domain and proprietary to client)

Search protocol and Sources

  • Standard search algorithms with an optimal balance between relevancy and noise
  • Multiple data sources including journal publications, conference posters, regulatory reviews, etc.

Ease of tracking

All clinical trial publications are listed in a separated source database and linked to unique clinical trial names

Model-friendliness

Designed to facilitate easy dataset generation, plotting, and data exploration

  • Clinical trial registries
  • Scientific Conference abstracts
  • Regulatory reviews like SBAs and EMEAs
  • PubMed Medline
  • COCHRANE
  • Proprietary information like CSRs
  • Proprietary Databases like EMBASE and OVID
  • Comparative safety and efficacy analysis even in the absence of head to head comparison trials
  • Link scale biomarkers to clinical outcomes
  • Understand better the dose response relationship for a particular drug or drug class
  • Bridge to new indications
  • Optimize the trial design and predict or improve the trial outcome
  • Develop product differentiation strategies
  • Crohn's Disease
  • Ulcerative Colitis
  • Multiple Sclerosis
  • Rheumatoid Arthritis
  • Psoriasis
  • Type 2 Diabetes
  • Chronic Kidney Disease
  • Dyslipidemia
  • Dyslipidemia - CV Outcomes
  • Alzheimer's
  • Schizophrenia
  • Neauropathic Pain
  • Paclitaxel for MBC
  • HCV
  • Fibromyalgia
  • Non-Hodgkin's Lymphoma
  • Osteoporosis
  • Lower Back Pain
  • Osteoarthritis Pain
  • Glaucoma
  • Migraine

Exclusive data model

Unique data organization structure that is developed keeping the specific modelling interest

Focused scope

The database is developed to meet the specific objective and is confined to the literature, population and assessments of interest. The scope can be expanded on a progressive basis to ensure maximum flexibility and benefits to the clients

High quality data

  • Extensive quality process that involves manual QC complimented with semi validations and graphical outputs
  • Enforce data standards like MedDRA, WHO drug dictionary, ICD efficacy and biomarker
  • Outcomes
  • Reliable high quality data that can be readily used for analysis

Confidentiality

  • On an exclusive basis these databases can be expanded with proprietary data to make them more comprehensive
  • Customization in client defined data formats
  • Protection of intellectual property
  • Designed and managed by experienced modelers proven valuable in drug development decision
  • Updated semi-annually to enable time critical analysis and decisions
  • Ancillary services: M&S consultancy by QS and customization by Excelra
  • Pharma and Biotech companies
  • Regulatory bodies
  • Payer groups
  • Pharmacometricians (PK-PD modeling groups)
  • Modeling and Simulation Consultants
  • Academicians
  • Health economic outcomes research groups
  • Clinical development groups
  • Clinicians
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