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Clinical Trials White Papers

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1-15 of 133 results
Reliable, Long-range Wireless Sensors for Environmental Monitoring
| By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.
Contract Research & Services > Clinical Trials > White Papers
Sciences Radiolabelling Brochure
| By Almac
Trust Almac with your 14C radiolabelling requirements and we will offer advice on the most appropriate label position for your molecule, including synthetic feasibility and metabolic stability.
Contract Research & Services > Clinical Trials > White Papers
Commerical Packaging
| By Almac
- Complementary US and UK operations, - Quality-driven, flexible packaging solutions, - Market leader for product launch of niche / orphan drug products, - Solid oral dose and biopharmaceutical packaging, - Packaging and artwork design, - Full serialisation and 2D matrix barcoding solutions.
Contract Research & Services > Clinical Trials > White Papers
Providing an Unparalleled Range of Contract Pharmaceutical Development and Manufacturing Services Globally for Over 40 Years
| By Almac
Only we can combine the expertise from our range of specialised services to provide you with the right solutions to help you develop and commercialise your products.
Contract Research & Services > Clinical Trials > White Papers
Building the Next Generation IRT: An Exclusive Look Under the Hood of IXRS®3
| By Almac
Interactive Response Technology (IRT) systems - used to manage patient interactions and drug supplies during clinical trials - perform a range of functions for sponsors, drug depots, and investigative sites. Yet, they are typically viewed by sponsors as a "painful necessity" rather than as a welcome, invaluable tool. That perception exists because the underlying technology is outmoded, and the user's experience is stuck in the pre-Internet era. While established systems are "tried and true" in that they have supported thousands of clinical trials over the years, they can also be tired and cumbersome.
Contract Research & Services > Clinical Trials > White Papers
Introducing Direct to Patient Shipments
| By Almac
Almac will ship the Clinical Trial Material (CTM) to participating clinical sites, where the drug is to be stored. Both shipping and storage of the CTM will follow standard procedures. Sites will interact with the Interactive Response Technology (IRT) provider in the usual way to obtain a kit assignment.
Contract Research & Services > Clinical Trials > White Papers
Bioanalysis of Biosimilars
| By PRA Health Sciences
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. Immunogenicity assays are used to determine and further characterize any anti-drug antibodies (ADA) formed during these studies. These analytical methods are pivotal for establishing similarity of biosimilar products as compared to their reference compounds.
Contract Research & Services > Clinical Trials > White Papers
ECG Assessments During the Development of Oncology Compounds
| By PRA Health Sciences
Assessment of ECGs during the development of oncology compounds is challenging. Toxicity of these compounds often precludes the inclusion of healthy volunteers while a higher variability of ECG parameters in oncology patients can be expected due to disease, comedication, and co-morbidities. Recently, it was shown that the extraction of ECG data using the High Precision QT technique of iCardiac and Exposure Response analysis can result in a conclusive ECG assessment with a limited number of volunteers. Applying these techniques in a small-sized oncology study with dedicated PRA staff presents a unique opportunity for a conclusive and efficient cardiac safety assessment by ECG.
Contract Research & Services > Clinical Trials > White Papers
Transform Clinical Development Through Advances in Risk-Based Monitoring
| By Quintiles
This paper shares the challenges of clinical development along with an approach to trial execution gleaned from years of executing trials with risk-based monitoring (RBM) policies and processes.
Contract Research & Services > Clinical Trials > White Papers
Integration of Molecular Biomarkers into Clinical Development
| By Quintiles
In the first of this two-part series, strategic drug developers Eric Groves, Jason Hill and Christopher Ung explain why biopharma cannot afford to ignore the growing surge of interest in biomarkers in oncology and discuss their critical role in the modern-day clinical development process.
Contract Research & Services > Clinical Trials > White Papers
Personalizing Oncology with Genomics
| By Quintiles
Next-generation sequencing will transform oncology clinical trials and treatments for cancer.
Contract Research & Services > Clinical Trials > White Papers
Biomarkers: Recent Advances in Their Application to the Treatment of Hematologic Malignancies
| By Quintiles
Biomarkers hold promise in the diagnosis, prognosis and therapeutic stratification of hematopoietic malignancies. These heterogeneous diseases - including multiple myeloma, lymphomas and leukemias - are frequently characterized cytogenetically with diagnoses supported by genetic, immunohistochemical and flow cytometric analyses.
Contract Research & Services > Clinical Trials > White Papers
Integrating Biomarkers in Alzheimer’s Disease Trials
| By Quintiles
Review of compliance with biomarker assessments in Alzheimer’s disease clinical trials.
Contract Research & Services > Clinical Trials > White Papers
Biomarkers: Key to Better Rheumatoid Arthritis Drug Development and Treatment
| By Quintiles
Rheumatoid arthritis (RA) affects approximately 1% of the world’s population with an ever-increasing burden on health, quality of life and the economy.
Contract Research & Services > Clinical Trials > White Papers
Designing Wellness for Fun and Satisfaction: Gummies - Based Nutrition
| By Softigel pbr
The gummy delivery form for vitamins, minerals and supplements is the single-largest source of growth among the supplements category. Vitamin users report preference for gummy/soft chewable products because these offer not only pleasure and a fun experience, but efficacy and convenience. The selection of materials during the design process of the formula is critical for the final product in order to meet the expectations of the consumers, which is to find a healthy product that will give them a delicious reward as well. Based on the design and development process, this paper reviews review in detail the stage of selection of materials and validation as a critical phase to obtain a product that represents quality and stability as well as the specific requirements of the costumers and the consumers.
Contract Research & Services > Clinical Trials > White Papers
1-15 of 133 results