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
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...
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...
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
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...
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...
Clinical Research Solutions
6 Unique Challenges Hindering Oncology Clinical Trials
The research for cancer treatment is moving forward at a rapid pace. We're witnessing a shift from chemotherapy protocols to MTAs (molecularly targeted agents) for immunotherapies in particular....
Clinical Research Solutions
Pharmaceutical Consulting during Product & Business Development
To stay competitive in the pharmaceutical field, pharmaceutical companies need to have access to legal, product and clinical development, business strategy, and human resources experts. Startups...
Regulatory Sciences
Three Steps Towards Complying with Nitrosamine Regulations
All Marketing Authorization Holders (MAH) of medicines for human use are facing what might feel for many, as a new requirement: review their drug products on the possible presence of nitrosamines....
FSP Solutions
5 Ways a Functional Service Provider Can Support Your Clinical Development Project
When pharmaceutical companies launch a clinical trial or reach a certain phase of Clinical Development, with only the support of their in-house employees, the additional workload often becomes too...
Life Sciences Data Analytics: The Importance of Big Data
Big data is hitting us from all angles, and life science industries are not being left out. Why? Your life depends on it, literally. Life sciences generate lots of large and complex data every single...
Clinical Research Solutions
6 Compliance Tips to get FDA Approval for Your Pharmaceutical Project
FDA Approval Process Overview The Food and Drug Administration (FDA), as part of the United States (US) Department of Health and Human Services, is the regulatory agency responsible for the review,...
Deviations: Beyond the Basics
There are plenty of guidelines and instructions on implementing a deviation system in a pharmaceutical/medical device company. However, there is a big difference between theory and practice when it...
Why the FDA Should Never Be Your First Inspection
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...
FDA's Top 483 Observations for 2018: A Reflection of Industry’s Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year's Form 483 observation metrics issued by each product center. Inspections ending between 10/1/2017 and 9/30/2018, for...