Clinical Research Solutions
Enterprise Resource Planning (ERP) Systems in the Medical Industry
Drug and medical device development and manufacturing is a complex process that involves multiple supply chains, various monitoring systems, and countless players from R&D to market. Due to the...
Clinical Research Solutions
Medical Device Regulation in the EU in the Midst of the COVID-19 Pandemic
Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device...
Clinical Research Solutions
Overlooking Your QMS Could Cost You
A Quality Management System (QMS) bridges an organization's individual compliance practices with regulatory requirements. It establishes the infrastructure and oversight requirements for...
Digital Transformation
Improve your R&D Strategy with These 6 Tips
In 2017, R&D investments in the pharmaceutical space reached more than $70 billion, with projected figures of over $200 billion by 2024. Pharma is one of the two sectors with semiconductors that are...
Clinical Research Solutions
FDA Guidance for Non-COVID-19 Related Clinical Trials During the Pandemic
In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...
Clinical Research Solutions
FDA Works to Accelerate the Development of COVID-19 Treatments with New Guidance Documents
On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19. With these documents, the Agency intends to...
Clinical Research Solutions
Clinical Trials in the Midst of COVID-19, Part One: European Medicines Agency (EMA)
Disclaimer As of April 23, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these...
Digital Transformation
Questions to Ask Before Implementing Data Standards in Science
In order to optimize the storage and reuse of data within your organization, we recommend that you consider implementing data standards throughout your business. In our previous blog post "An...
Clinical Research Solutions
EMA Extends Due Date for Nitrosamines Impurities Risk Assessment Due to COVID-19
EMA has extended the deadline to assess the risk of nitrosamine impurities to 31 March 2021. This decision was made based on the reports of the challenges encountered in meeting the original deadline...
An Introduction to Scientific Data Standards
With automation becoming more mainstream in science, vast quantities of data are now generated by many organizations every day. This deluge of data is often managed ineffectively, limiting the...
Clinical Research Solutions
5 Scenarios That Need a Clinical Operations Team
New drug development is a costly, lengthy and risky process. Hurdles spring up at every stage and today's landscape puts sponsors under more pressure than ever before. Clinical trials are becoming...
Clinical Research Solutions
Do You Need a Project Management Office (PMO)?
There is more to a project management office than managing projects. In fact, the project management office (PMO) acts as both a watchtower and a lighthouse to guide strategic initiatives toward...
Clinical Research Solutions
7 Medical Writing Tips for the Oncology Field
In the wake of the 21st Century Cures Act (December 2016), the FDA has switched gears to accelerate the development of novel therapies and speed up the review process, particularly in the field of...
Clinical Research Solutions
Changes in Medical Device Regulatory Requirements in Europe (2021)
In May 2021, the new European regulations on medical devices (EU MDR) will take full effect. Organizations face a unique set of compliance challenges, mainly due to the numerous changes and additions...
Clinical Research Solutions
FDA: CGMP Consultant Recommendation
Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a...
Clinical Research Solutions
The Importance of the eCTD Structure for FDA Approval
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...