Pharma Focus Europe
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Clinical Trials

The field of clinical trials is continually changing, and more and more new clinical research is being published. The primary approach for gaining an accurate assessment of a treatment's impact on patients is usually recognized as clinical trial services. A developing trend in the medical sector is the use of clinical trials to evaluate the degree of safety and efficacy of newly discovered drugs and medical devices. They offer the clinical trials industry a trustworthy platform for assessing the safety and efficacy of novel medicines. A context-giving framework is provided by the historical perspective, current state, and plan for clinical trials.

Addressing the Unmet Needs in Respiratory Disease Treatment with Inhaled mRNA Medicines

Advancements in medical science have continually pushed the boundaries of what is possible in healthcare...

Bringing New Treatments to Patients with Rare Diseases

Designing and Conducting Effective Gene Therapy Trials

Today there are more than 10,000 known rare diseases, defined by the European Union as conditions that affect less than 1 in 2,000 people

Digital Biomarkers in Neuroscience – Benefits for Clinical Development, Physicians, and Patients

Disorders of the CNS, which include a wide range of psychiatric and neurological conditions such as Alzheimer’s disease, schizophrenia and depression, have a profound impact on individuals and their families.

Future of Clinical Trials and Technology Innovations

Clinical trials are an essential part of the development of new medical treatments and procedures, and they help to ensure that new interventions are safe and effective for patients above all.

Blood to Plasma Ratio: An Important Determinant of the Pharmacokinetic Behavior of Drugs

The blood-to-plasma ratio (B/P ratio or Rb) is an important parameter in pharmacokinetics (PK) that reflects the distribution of a drug between red blood cells (RBCs) and plasma.

Clinical Trial Project Management Practices Review

The practices associated with project management of clinical trials is crucial to the success of that trial. As the primary point of contact between the sponsor, study team, and regulatory authorities, the project manager is responsible for ensuring that the study is conducted in compliance with all relevant guidelines and regulations.

Pooling: An Untapped Clinical Supply Chain Strategy

One of the most challenging responsibilities a Clinical Supply Chain Manager has is to determine a reliable supply forecast that stands up to the complexities of the clinical trial design and the various scenarios that can occur during trial conduct.

Decentralising Clinical Trials for Better Drug Formulations

Achieving Patient Data Integrity & Fulfilling Diverse Pharma Needs

The pandemic significantly accelerated the decentralisation of clinical trials and saw more data being captured off-site, remotely from participants in real world settings.

BENEFITS AND CHALLENGES OF USING WEARABLES IN CLINICAL TRIALS

Wearable sensors have the potential to transform healthcare. In many instances, wearable sensors can pick up signs that a person is getting sick before even they realize it.

Low Rates of Stroke and Major Bleeding with Rivaroxaban Confirmed by Global Study

XANTUS pooled results study

Results of the pooled analysis of the global XANTUS real-world study programme were announced recently at the European Society of Cardiology (ESC) Congress in Barcelona, Spain. The study investigated the use of the non-vitamin K antagonist oral anticoagulant (NOAC) rivaroxaban for stroke prevention in patients with non-valvular Atrial Fibrillation...

Patient Recruitment in Asia

Reducing the clinical burden

Today, there are many innovative, new approaches to patient recruitment and the number continues to grow. The driver behind these innovations is the challenge that many western countries face in recruiting patients for participation in clinical studies.The concept of patient recruitment is quite simple. It involves recruiting the right patients...

Innovation in Clinical Trials

Clinical trial development has evolved significantly over the past few decades. Digital technology is increasingly used to improve clinical trial efficiency. Its use spans all phases of drug development, and impacts areas such as recruitment and retention of patients, wearables, virtual clinical trials, and health economics outcomes research. Lever...

Speed, Quality and Cost

Leveraging Australia to expedite clinical development

In recent years, the pharmaceutical industry has seen tremendous changes in the way it is expected to deliver new drugs to market: being under increasing pressure to expedite the development of new therapies, to decrease clinical study duration, and to drive new treatments through their clinical phases as quickly, safely and cost-efficiently as pos...

Design and Analysis of Cancer Clinical Trials for Personalised Medicine

Personalised medicine for cacner is a treatment module tailored to individual patients based on various factors including biomarkers. Different types of biomarkers are measured from the tumour, blood or urine using molecular, biochemical, physiological, anatomical, or imaging method before treatment or during the course of treatment.

THE AGGREGATE SAFETY ASSESSMENT PLAN

A valuable tool for clinical trial safety planning

Recently, a Drug Information Association / American Statistical Association-sponsored Interdisciplinary Safety Evaluation working group published a recommended approach to the aggregate assessment of clinical trial safety data.

Current Trends in Pharmacogenomics that will shape Clinical Trials

The complete human genome was published in March 2022, heralding a new era in pharmacogenomics, advancing genome analysis, and unlocking value additions in precision medicine.

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