Clinical Research Solutions
The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 1
The Benefit of the Common Application Form for GMO Applications GMO Application Not Included in Clinical Trial Regulation With the transition period for the Clinical Trial Regulation No 536/2014...
Clinical Research Solutions
Meet the Expert: Susanna Heinonen
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
Highlights from FDA's Analytical Test Method Validation Guidance
Recently, the FDA updated a long-standing, decades old guidance on analytical test method validation based on revisions of the ICH Q2(R2) guidelines. Traditional test method validation requirements...
Clinical Research Solutions
MLR Submission Content: Setting Yourself up for a Successful PRC Review
Having a highly efficient well-oiled Promotional Review Committee (PRC) machine is not just about having rock star reviewers and effective best practices in place. Although those are both critical...
Digital Transformation
What is a LIMS, and How Do I Know if I Need One?
What is a LIMS? At first, a Laboratory Information Management System (LIMS) sounds like something that would be useful in any lab. Isn't the purpose of a lab to produce information, and shouldn’t...
Clinical Research Solutions
Meet the Expert: David Lough
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
An Overview of the PSMF: Pharmacovigilance System Master File
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
Clinical Research Solutions
The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)
Introduction According to §63a of the German Medicinal Products Act (AMG), a pharmaceutical entrepreneur who places finished medicinal products on the market that are medicinal products within the...
Medical Information
The Role of Patient Support Services in the Evolving World of Cell & Gene Therapies (CAGTs)
Cell and Gene Therapies (CAGTs) represent a transformative step in medicine, offering unprecedented potential to treat and potentially cure diseases once deemed untreatable. However, the path to...
Clinical Research Solutions
The LPPV Network: An Essential Guide to Local Person Responsible for Pharmacovigilance
Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. Within the EU a pharmacovigilance system is defined as a system used by an...
Digital Transformation
Honing Your Veeva Vault RIMS Environment for Peak Performance
Regulatory requirements are a formidable challenge for early stage biotechs and top pharma alike. As health authorities continually revise guidelines across diverse markets, companies are tasked with...
Clinical Research Solutions
Meet the Expert: Thomas Chatzopoulos
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
A Guide to Solving Complex Life Sciences Challenges
Life sciences organizations are consistently inundated with decisions and challenges of varying scale. These can occur anywhere during the life sciences value chain, under any treatment modality...
Clinical Research Solutions
Understanding the PSUR and PBRER
Periodic Safety Update Reports (PSURs) play a pivotal role in ensuring the ongoing safety and efficacy of medicinal products once they've entered the market. While initial clinical trials provide...
Clinical Research Solutions
Meet the Expert: Kirsty Bryant
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
What to Expect During the NDA Review Process
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...