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Since the COVID-19 pandemic, clinical trials have transitioned from traditional monitoring methods towards a more flexible approach known as Risk-Based Monitoring (RBM). RBM offers a potential paradigm shift in the speed, efficiency, and costs for bringing new therapeutic, medical device, and diagnostic products to market. ​​ Drug and medical device development budgets face intense pressure, with US health care spending predicted to reach 20% of US GDP in the coming decade, d

companion-diagnostics-precision-medicine-cancer or cdx-precision-medicine-cancer-careCompanion Diagnostics (CDx) are a class of diagnostic devices used alongside a specific therapeutic drug to ensure the patient is likely to benefit, with increased effectiveness and reduced risk from side effects.   CDx are an essential component in a new wave of cancer treatments known as precision medicine.  These diagnostics have been described as a “GPS” for cancer treatment, enabling s

Laboratory Developed Tests (LDTs) play a key role in global healthcare, allowing health institutions to develop specific diagnostic tools that are not mass-produced or commercially available. During the COVID-19 pandemic, they received spotlight attention with an unprecedented demand for decentralized, rapid diagnostic tools. They play a vital role in many emerging trends, such as personalized medicine, gene expression profiling, and pharmacogenomics. The United States (US)

Regulatory authorities in the United States (US) and the European Union (EU) are responding to the growing role of Companion Diagnostics (CDx) for innovative therapies. These authorities differ in tactical implementation of regulatory coordination and approval. ​ In the US, the FDA acts as a central authority and requires contemporaneous submission for a drug and its companion diagnostic device. The EU has several parties involved in approval for drugs and CDx: the National C

Laboratory Developed Tests (LDTs) play a growing role in the transformation of public health and precision medicine. Last year, the U.S. Food and Drug Administration (FDA) announced plans to formally classify LDTs as medical devices, subjecting these tests to greater premarket review and post-market compliance. Leaders in life science innovation should prepare for government regulation scenarios by establishing effective risk mitigation strategies, and developing a competiti

On September 29, 2023, the FDA's announced introduction of a proposed rule to regulate Laboratory Developed Tests (LDTs) as IVDs that fall under the Food and Drug Cosmetic Act, marking a significant shift for the FDA to phase out the era of enforcement discretion for LDTs. The FDA intends to have great oversight of LDTs, wherein LDTs manufactured by laboratories would fall under similar enforcement approaches as IVDs. Increases in the prevalence (use), technological complexit

Clinical Trials are essential for developing new treatments, drugs, and medical devices. They are carefully designed and conducted to evaluate their safety and efficacy. However, conducting Clinical Trials also involves a certain degree of risk for the participants and the trial sponsors. Risk Management is, therefore, a critical component of any clinical trial. It involves identifying potential risks and implementing strategies to minimize or mitigate them. What is Risk M

Outsourcing can have many benefits such as : Redirecting your company resources to high added value tasks Gaining internal experience while working with external experts Working with highly qualified teams Being able to focus your internal resources on your company's core strengths Making sure to comply with regulatory requirements, especially when you enter new markets you don’t know Helping your team to focus on certain tasks while outsourcing other It can also be noted t

At Landrich Group, our relationships with our clients is key. It’s a decisive element allowing us to provide the best services to advance health care through clinical research and improve the lives of patients. Our talented and highly skilled team knows that each client is different and will create a unique experience tailored to our clients needs. We care about their needs as they are our own and make sure to supply the right tools and resources to help them reach their g

Some might think small CRO’s can not compete with big ones but it has been shown they can provide all the services needed. A small CRO can even offer: More flexibility and a trust-worthy service The access to a single point of contact which enable an easier collaboration An advanced personal client support A superior therapeutic expertise Competitive quotes while maintaining high satisfactory quality standards Choosing a small CRO can help you make the most out of your in