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...

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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...

Meet the Expert: David Lough

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...

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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...

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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...

Meet the Expert: Thomas Chatzopoulos

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...

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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...

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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...

Meet the Expert: Kirsty Bryant

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...

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Quality & Compliance

Maximizing Cost Efficiency: The Financial Advantages of Outsourcing Vendor Audits

In today's dynamic business landscape, organizations in the drug, biologics, and medical device industries face the dual challenge of delivering quality products while managing tighter budgets and...

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Quality & Compliance

FDA Publishes Guidance for CAR T Products

In January 2024, the FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products issued a guidance document- Considerations for the Development of Chimeric Antigen Receptor...

Clinical Research Solutions

The Importance of EU/UK QP Audits

In the highly regulated pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is paramount. One crucial aspect of this assurance lies in the oversight provided by...