Today many pharmaceutical companies and clinical research organizations (CROs) rely on disparate software solutions for different functional areas of clinical trials. Researchers are required to ingress data that sit in silos and don’t talk to each other, thus resulting in redundancy and decreased productivity. What if your entire clinical trial... read more →
Sep
07
Aug
18
The trial master file (TMF) or the new modern version of TMF, the electronic TMF (eTMF), is the compilation of all essential documents that are collected before, during, and after the conduct of a clinical trial. This repository of documents and study artifacts referred to in Article 15(5) of Directive... read more →
Aug
04
A variety of approaches have been used by clinical trial sponsors to ensure that monitoring obligations are fulfilled. In the year 2013, the U.S. Food and Drug Administration (FDA) recommended the industry to shift from traditional monitoring to remote and risk-based monitoring to increase efficiency, optimize resources and reduce the... read more →
Apr
13
When ICH GCP E6 (R1) was introduced in the year 1996, clinical trials were largely paper-based, and spreadsheets were widely used as the manual computation and compilation tool for managing various trial processes. Now almost two and half decades later, with industry’s adoption of revised ICH GCP E6 (R2) guidelines... read more →
Mar
17
The new age clinical research sites are becoming increasingly selective about which sponsor/CRO they would want to work with on industry-sponsored clinical trials. One selection criterion that sites stringently look out for is how efficient, timely and transparent is the investigator/site payment process. Sponsors and CROs who manage the financial... read more →
Mar
05
The International Council for Harmonization’s addendum to the ICH E6 Guideline for Good Clinical Practice (ICH E6 R2) and EU regulation 536/2014 strongly advocates the adoption of risk-based monitoring (RBM) of clinical trials. Despite the regulator’s advocacy and the perceived benefits of RBM, industry adoption has been quite slow due... read more →
Feb
28
Are you overwhelmed with the heavy responsibility of evaluating a novel clinical trial management system (CTMS) for your organization, but have little experience with technology jargon? Are you unsatisfied with your current implementation of CTMS?? Well folks, if the answer is YES, stay tuned as we attempt to provide you critical... read more →
Apr
05
The changing expectations of the users and their needs drive the way software development companies metamorphose to modify their approaches for bespoke software development. User experiences drive the way systems are developed today adapting to a growing number of trending technologies, seamlessly integrating them to deliver comprehensive solutions. The Mobile... read more →
Nov
28
Research Site is critical to the success of Clinical Trial The front line of clinical trials is the sites. It is the clinical research site’s performance and compliance that will determine the ultimate fate of the investigational product in a clinical trial. Site research personnel usually include the principal investigator,... read more →
Oct
20
Microsoft Excel is widely used for creating and maintaining spreadsheet documents. Almost all companies invariably rely on Microsoft Excel, and most of the time departments end up maintaining some information and database in an Excel worksheet. The powerful feature of Macros enables users to even build small applications themselves without... read more →
Sep
29
When you outgrow your Access database, consider migrating from MS Access to Oracle Application Express (APEX). Oracle APEX is a ‘no-cost’ web application development tool of Oracle database. With Oracle APEX, you can build highly secured, scalable, and responsive web application using only your web browser. The declarative programming framework... read more →
Sep
19
When is Access appropriate? Microsoft Access targets individual users or small teams that need to track and manage business information. Users familiar with Microsoft Office tools can easily develop a personal database or a small application in Microsoft Access without requiring any involvement of software developer. Microsoft Access based application... read more →
Jul
09
Design Principles of Web Database Applications As companies look to migrate from their legacy databases to web based cloud enabled databases, it is important to understand that scalability of a database for web application hinges on how well the database is designed. A database, regardless of the technology used, is... read more →
Jun
23
Investigator Payment accounts for a significant portion of a clinical trial budget. On an average, investigator payments account for half of the study trial budget. Therefore, it is imperative to get the investigator payment process right. You have to strike the right balance for establishing and managing the investigator payment... read more →
Jun
20
Oracle Application Express (APEX) is a rapid application development tool of Oracle database and is used to develop sophisticated enterprise web applications. Unlike other Oracle Development tools, Oracle APEX is a no cost, fully supported feature of Oracle database. It is included in all editions of Oracle database, including Oracle... read more →