IDDI
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ID-SPECKTACLE DEMO
ID-Spectackle is a user-friendly graphical interface to guide statistical programmers.
This tool is meant to help and prepare the ADaM Specifications, to create Define-XML for submission. It helps to limit a lot of manual input by automating the metadata collection and provide guidance to fill-in the specifications. As the basis of the specifications, a SAS® Macro collects metadata, with support of the ADaM IG and NCI Controlled Terminology.
This automated process presents multiple advantages:
- it avoids error-prone copy-pasting of redundant information among sources,
- it ensures that specifications and datasets are aligned,
- it provides consistency checks with completion rules,
- the evolution of standards can be implemented directly in the system,
- it ensures that the specifications format is compliant with the one from P21,
- it clarifies and deploys a standard process company wide.
VISIT : IDDI.com
More info: info@iddi.com
Переглядів: 26

Відео

Randomization and Trial Supply Management - RTSM
Переглядів 30610 місяців тому
Improving Speed & Quality Through the Clinical Trial Industry’s ONLY Biostatistics-Driven Randomization and Trial Supply Management (RTSM) By combining Mentor RTSM know-how with IDDI’s statistical expertise, we ensure that your studies are configured in the most reliable and efficient way, securing your trial integrity. Our statisticians are involved from start to end to provide the most approp...
IDDI Clinical Data Management Services
Переглядів 10211 місяців тому
IDDI is an expert clinical data services and high-level strategic consulting contract research organization (CRO), providing agile clinical trials services for pharmaceutical, biotech, and medical device/diagnostic companies. With over 30 years and more than 1300 clinical trials of experience, IDDI is a valuable partner in the design, conduct and analysis in clinical research through optional s...
IDDI Corporate Video 2024
Переглядів 317Рік тому
IDDI - BIOSTATISTICAL & eCLINICAL SERVICES FOR PHASE I-IV TRIALS SINCE 1991 Trial Design - Randomization - Data Management - Biostatistics IDDI is an expert clinical data services and high-level strategic consulting contract research organization CRO, providing agile clinical trial services for pharmaceutical, biotechnology, and medical device/diagnostic companies. - Proven scientific and data ...
Happy Holiday Season 2023
Переглядів 56Рік тому
Happy Holiday Season from the IDDI team. Thank you for all your support throughout the year. We wish you a great holiday season and a wonderful 2024! www.IDDI.com
Does Real World Evidence have a role in Precision Oncology
Переглядів 271Рік тому
The FDA instituted a program for Accelerated Approval in 1992, which allowed for approvals on the basis of surrogate endpoints for drugs treating serious conditions that filled an unmet medical need. The Food and Drug Administration Safety Innovations Act, passed in 2012, allows accelerated approvals for appropriate drugs and indications by evaluating the effects of drugs on surrogate markers. ...
GPC - A novel statistical method for outcome analysis & reporting of prioritized composite endpoints
Переглядів 1,6 тис.Рік тому
In cardiovascular clinical trials, the primary endpoint often consists of multiple survival outcomes. These outcomes are commonly evaluated by a time-to-first event composite endpoint analysis. A time-to-first event analysis, however, has shortcomings in evaluating a treatment effect. It emphasizes each patient’s first event, which is often the outcome of lesser clinical importance. In addition...
Supporting Shared Decision-making and Communication in Breast Cancer: The ShareView Project
Переглядів 145Рік тому
Several treatments are available for patients with breast cancer (BC). Decision aids (DAs) are interventions that provide patients with information about available therapies, clarifying the congruence between decisions and personal values, and fostering shared decision-making (SDM), which is known to increase quality of care. In this context, the ShareView project, short for “Supporting shared ...
IDDI Corporate Video - 2023
Переглядів 354Рік тому
IDDI, BIOSTATISTICAL & eCLINICAL SERVICES FOR PHASE I-IV TRIALS SINCE 1991. www.IDDI.com Trial Design - Randomization - Data Management - Biostatistics IDDI is an expert clinical data services and high-level strategic consulting contract research organization CRO, providing agile clinical trial services for pharmaceutical, biotechnology, and medical device/diagnostic companies. - Proven scienti...
WEBINAR: The Added Value of Biostatistics Driven Randomization and Trial Supply Management System
Переглядів 2102 роки тому
Randomization and trial supply management (RTSM) and electronic data capture (EDC) technologies and systems are essential to managing clinical trials. As clinical trials become increasingly complex, biostatisticians become even more essential, providing the needed insight to understand protocol-specific randomization nuances and make optimal randomization decisions to improve trial outcomes. In...
HAPPY HOLIDAY SEASON 2023
Переглядів 982 роки тому
HAPPY HOLIDAY SEASON FROM IDDI ! IDDI : BIOSTATISTICS & eCLINICAL EXPERTS - www.IDDI.com Founded in 1991, IDDI is an expert clinical data services and high-level strategic consulting contract research organization offering Trial Design - Randomization - Data Management and Biostatistics services for Pharmaceutical, Biotech & medical device/diagnostic companies. Contact: info@iddi.com - More inf...
Why do so many phase III trials fail
Переглядів 2 тис.2 роки тому
Of all drugs that enter clinical development, 4 in 5 fail to get approved, and half of the failures occur in phase 3. Join the IDDI’s experts in this webinar and learn on statistical explanations for a large proportion of Phase III clinical trials failures, and how to address both the overestimation of treatment effects, and the misinterpretation of P-values via Bayesian methods. More info on w...
Optimizing Rare Disease Trials: Trial Design & Execution
Переглядів 4122 роки тому
Join August Research and IDDI’s experts in the 60-minute complimentary webinar to gain insights into trial design and execution strategies to optimize rare disease trials! TRIAL DESIGN: an innovative statistical method enabling you to leverage higher power of data with smaller sample sizes. TRIAL EXECUTION: providing insights on how to maximize operational efficiencies in rare disease trials th...
Webinar: The Benefit-Risk assessment of new treatments: The Health Technology Assessment process
Переглядів 2562 роки тому
The increasing cost of new treatments, notably of cancer medications, is prompting policymakers to ask if newer therapies are worth their cost. Most European nations use health technology assessment (HTA) to determine the value of new drugs, decide whether insurance should reimburse them, and determine payment. In France, The Transparency Commission (TC) evaluates each drug’s added benefit in r...
Randomization Services 2022
Переглядів 1042 роки тому
Randomization Services 2022
Webinar: Conversation between a sponsor and a statistician about phase II/III trials in oncology
Переглядів 7602 роки тому
Webinar: Conversation between a sponsor and a statistician about phase II/III trials in oncology
IDDI - Your trusted CRO partner for oncology clinical trials
Переглядів 772 роки тому
IDDI - Your trusted CRO partner for oncology clinical trials
Risk-Based Fraud Detection: How Centralized Monitoring Can Boost Data Quality
Переглядів 1,5 тис.2 роки тому
Risk-Based Fraud Detection: How Centralized Monitoring Can Boost Data Quality
IDDI- Clinical Data management Services
Переглядів 913 роки тому
IDDI- Clinical Data management Services
Assessing treatment efficacy in early-phase oncology trials
Переглядів 1,4 тис.3 роки тому
Assessing treatment efficacy in early-phase oncology trials
Holiday Season 2021_IDDI
Переглядів 2033 роки тому
Holiday Season 2021_IDDI
Assessing activity in early-phase trial in oncology: current designs for expansion cohorts & phase 2
Переглядів 1,3 тис.3 роки тому
Assessing activity in early-phase trial in oncology: current designs for expansion cohorts & phase 2
IDDI 30 YEAR ANNIVERSARY
Переглядів 5063 роки тому
IDDI 30 YEAR ANNIVERSARY
Webinar: Assessing Treatment Benefit in Immuno-Oncology
Переглядів 1353 роки тому
Webinar: Assessing Treatment Benefit in Immuno-Oncology
The Net Treatment BENEFIT- Generalized Pairwise Comparisons Method - GPC
Переглядів 1,2 тис.3 роки тому
The Net Treatment BENEFIT- Generalized Pairwise Comparisons Method - GPC
Webinar: Phase I trials in oncology: Pros and cons of current designs
Переглядів 2,6 тис.3 роки тому
Webinar: Phase I trials in oncology: Pros and cons of current designs
2021 09 21 17 00 Biostatistics and SARS CoV 2 Research, Policymaking, and Communication
Переглядів 2243 роки тому
2021 09 21 17 00 Biostatistics and SARS CoV 2 Research, Policymaking, and Communication
Estimands in Oncology are we censoring for the right reason
Переглядів 1,3 тис.3 роки тому
Estimands in Oncology are we censoring for the right reason
ID-Base - IDDI EDC SYSTEM
Переглядів 1543 роки тому
ID-Base - IDDI EDC SYSTEM
Practice Oriented Pragmatic Trials can Integrate Innovations More Rapidly in Evidence Based Medicine
Переглядів 953 роки тому
Practice Oriented Pragmatic Trials can Integrate Innovations More Rapidly in Evidence Based Medicine