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First Steps in Laboratory Dataset in SAS

Clinical Programming Team

The laboratory dataset is one of the core safety datasets and, at first glance, it could appear intimidating, with multiple tests and visits per patient. This article will illustrate checks that are worth applying at the very beginning of programming work – these could be in addition to the standardized process of domain validation.

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Topics: Laboratory Datasets, Safety Dataset, Statistical Programming, SAS Programming, SAS, Clinical Programming, CDISC Standards, CDISC SDTM, SAS Macros, SAS Datasets, SDTM, Case Report Form (CRF), SDTM Domains, CDISC Guidelines, CDISC

Implementing Electronic Data Capture (EDC) systems in Clinical Trials

Clinical Data Management Team

Clinical Trial Management Systems (CTMS) are an important part of every clinical trial. Selecting the right CTMS helps address inefficiencies on the operational side of research, such as clinical trial planning, preparation, performance and reporting. As more and more pharma and biopharma sponsors start to recognize the potential opportunities that exist with EDC-CTMS integration, there is a growing need to address the complex process of electronic data capture (EDC) implementation.

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Topics: Clinical Data Management, Electronic Data Capture, Paper-Based Studies, eCRF, Case Report Form (CRF), CDISC, CDISC CDASH, Outsourcing Solutions

What Defines Quality in Medical Writing?

Medical Writing Team

A quick trawl of the internet reveals that the majority of medical writing services are sold, in part, on the basis of quality, but what really is quality and why do medical writers think it is so important?

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Topics: Medical Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report, Quality Assurance

[Video] Tipping Point Analysis in Multiple Imputation for Binary Missing Data

Statistical Consultancy Team

In this Statistical Knowledge Share Video our Senior Statisticians, Niccolo, presents an example on simulated data of Tipping Point Analysis in Multiple Imputation for Missing Data.

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Topics: Tipping Points Analysis, Multiple Imputation, Missing Data, Statistics, Statistical Knowledge Share

Pharmacovigilance: The Regulatory Outlook

Pharmacovigilance Team

2012 saw the introduction of good pharmacovigilance practices (GVPs) in the European Union (EU) and since then, the industry has experienced a huge amount of change, including the introduction of the new EudraVigilance system in 2017. The new system, due to be fully implemented in 2019, is a European data processing network and management system designed to allow companies to report and evaluate suspected adverse reactions both during drug development and on an ongoing basis.

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Topics: Good Pharmacovigilance Practices, Eudravigilance, GVP Module VI, ICH E2B(R3), International Conference on Harmonisation (ICH), Regulatory Requirements, Good Clinical Practice (GCP), New Pharmacovigilance Legislation, Safety Database, European Medicines Agency

Risk-Based Monitoring and the Need for Programmers and Statisticians

Statistical Consultancy Team


The ICH E6 on Good Clinical Practice was updated on 9 November 2016, the first addendum for 20 years. Sections 5.0 on Risk and 5.18.3 on Extent and Nature of Monitoring in particular created an increased need for Risk-Based Monitoring (RBM) and Centralized Monitoring (CM). The details of how this may be covered and the increasing evolution of a risk in the industry have been noted. The required changes involved create a number of different team roles. These include opportunities for biostatisticians and statistical programmers - players who may not have been so directly involved in onsite monitoring, a more traditionally clinical domain.

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Topics: Risk Based Monitoring, International Conference on Harmonisation (ICH), ICHGCP E6, Centralized Monitoring, Fraud Detection, Source Data Verification (SDV), On-Site Monitoring, Visualization

The Problems (and solutions) of Real World Data in the Pharma Industry

Clinical Programming Team

Our job as Real World Data programmers is to put the whole patient data, usually spread across multiple tables, into one coherent history. This might lead to some surprising discoveries such as: patients with records before birth/after death, patients changing sexes multiple times, and finding non-valid codes. Such discrepancies are usually pretty easy to classify as data issues and are easy to handle. On the other hand we might encounter real world data events that cannot be as easily classified and need special approaches such as; patient receiving multiple Rx’s for the same drug on one day, or receiving a new Rx’s before the previous runs out, patients visiting the Doctor’s office / Emergency Room during their hospital stays, patients changing wards/level of care multiple times during one hospital visit, and finding valid but non-billable codes in insurance claims data. In this post we share some commonly encountered problems (and our solutions) related to Real World Data analysis.

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Topics: Real World Data, Clinical Programming, Observational longitudinal databases, Outcomes Research

Patient Reported Outcomes (PRO) to Support Medical Product Labeling Claims

Statistical Consultancy Team

With encouragement from the U.S. Food and Drug Administration (FDA), using Patient Reported Outcomes (PRO) data to claim labeling became more and more popular. Well-defined and reliable PRO can be used to support a claim in medical product labeling. [1] It is found that there are an increasing number of regulatory submissions for new drugs to provide PRO data to support claims. DeMuro et al. (2013) [2] have reviewed drug approvals by both FDA and EMA for the years 2006–2010. They found that out of 75 drugs approved by the EMA, 35 (47%) had at least one PRO related claim approved by the EMA compared to 14 (19%) for the FDA.

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Topics: Patient Reported Outcomes, medical labeling, Biostatistics Consulting, PRO Instrument, FDA, European Medicines Agency, Electronica Patient Reported Outcome (ePRO), Statistical Analysis Plan

ICH E2B(R3): Are You Ready For The New Update?

Pharmacovigilance Team


The International Conference on Harmonisation (ICH) has defined E2B as the international standard for transmitting medicine adverse event reports. The ICH E2B document includes message standards required for effective transmission of individual case safety reports (ICSR). Eventually, the need for the exchange of high volume of safety information world-wide efficiently and automatically has led to periodic revisions of the E2B document. Since 2001, when E2B(R2) was implemented, there have been many developments in regulatory reporting requirements and pharmacovigilance practices. Recently, the ICH E2B(R3) and M2 Expert Working Groups (EWGs) jointly developed an implementation guide on the standards adopted for electronic transmission of ICSRs. It includes new requirements that will require compliance by product manufacturers (and the organizations that assist them with reporting safety information).

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Topics: ICH E2B(R3), Pharmacovigilance, Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), Adverse Events (AEs), Patient Safety, Good Pharmacovigilance Practices, Safety Database, Standard Operating Procedures (SOP)

The Analysis of Direct and Indirect Pathways in Observational Studies

Statistical Consultancy Team

The blog was orginally presented by one of our statistical consultants at the Statisticians in the Pharmaceutical Industry (PSI) 2017 conference.

Inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), are a major cause of work disability. Despite clinical progress in inflammation control and associated improvements in outcomes, work disability remains an issue for AS patients, and other underlying causes, such as fatigue, have been postulated. We have used data from an observational study, which followed a large cohort of AS patients in routine clinical practice for 12 months, to investigate the longitudinal relationship (data at baseline, 6 and 12 months) between fatigue and work disability in the presence of other recognised confounders. Initial results suggested possible inter-relationships between the effects of fatigue and anxiety/depression, leading to a post-hoc hypothesis that:

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Topics: Observational Studies, SAS Macros, Biostatistics Consulting, Statistics, Statisticians in the Pharmaceutical Industry (PSI), Inflammatory Rheumatic Diseases, PROC GENMOD

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