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Showing results 65 - 80 of 399 for .

Showing results 65 - 80 of 399 for .

Global Market Assessment of the Potential to Move the Site of Care for a Minimally Invasive Surgical Procedure
This case study explores a global market assessment for an international medical device manufacturer seeking evidence generation and strategies for shifting the site of care for a minimally invasive surgical procedure from the inpatient to outpatient setting.
Improving Study Start Up and Recruitment for a Drug-Device Clinical Trial
This case study explores the challenges faced in study start up, recruitment and data management.
Incorporating the Patient Voice to Improve Ulcerative Colitis Recruitment
Dr. Joan Meyer, Covance Executive Director of Strategy & Planning for iiGM, recently discussed her team's efforts to be understand patients' opinions about inflammatory bowel disease trials and develop patient-centered clinical strategies to improve study recruitment.
Market Access Insights to Support a Clinical Development Plan
Our consulting team provided a robust Clinical Development Plan (CDP) informed by key market access considerations. They developed reimbursement insights and guidance for optimal pricing and successful market uptake.
East Meets West: Creating a Custom Solution in China to Meet Complex Microbiology Testing Requirements
This case study discusses the challenges needed support a study in China to meet CFDA guidelines.
Optimizing Protocol Design and Enhancing Patient Enrollment
An emerging biopharmaceutical company was considering development of a pharmacologic agent for treatment of patients with diabetic kidney disease (DKD).
Successfully Piloting a Virtual Real-World Evidence Study
A mid-sized pharmaceutical company needed to conduct a completely virtual study and asked Covance to support their efforts based on their past experience with virtual real-world evidence programs.
Providing Regulatory Support in China for a New Compound
A small to mid-size pharmaceutical company in India was developing a new combination treatment for complicated Urinary Tract Infection (cUTI). They were starting studies in the U.S. and EU but also wanted to evaluate their treatment in China with a Phase III trial. They chose Covance to support their efforts, provide a regulatory strategy and facilitate interactions with the China Food and Drug Administration (CFDA).
Reimbursement Assessment and Evidence Generation Strategy
Our consulting experts provided insights into evidence requirements and timeline considerations for market entry and reimbursement, stakeholder perceptions and decision-making factors likely to impact reimbursement, pricing and uptake and evidence generation activities.
Rescuing Patient Enrollment for a Rare Mutation
A mid-sized pharmaceutical company needed to conduct a completely virtual study and asked Covance to support their efforts based on their past experience with virtual real-world evidence programs.
Tactical Adaptations in Antibiotic Development for Virtual Biotech's
A virtual biotech company chose Covance to conduct two Phase III clinical trials for a new antibiotic treating life-threatening skin infections, such as methicillin-resistant staphylococcus aureus (MRSA).
Real-Time Data. Real-World Impact. Infographic
Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies.
Use of Cilia Beat Frequency in an In Vitro Airway Model (EpiAirway-FT) as a Tool for Assessing Viability
TSRC 2018 -- Human respiratory tract cilia play an essential role in clearing mucus and debris from the airway (mucociliary clearance). This important defence mechanism protects the lungs from aerosolised pathogens and pollutants and can be directly attributed to cilia beat frequency (CBF). Two well characterised 3D tissue models on the market are EpiAirway tissues and MucilAir. The Sissons-Ammons Video Analysis (SAVA) system is a combination of high-speed video, microscopy and image...
Analytical Tools Supporting Biodistribution Studies for Cell and Gene Therapy
EBF 2018 -- Biodistribution studies are critical components when assessing the preclinical safety evaluation of cell and gene therapy molecules. These studies are performed to assess the distribution, persistence and shedding of cell and gene therapy molecules to target and non-target tissues. Performing biodistribution studies can be challenging and time consuming, with one of the biggest concerns being cross contamination during all phases of these complex studies, in particular during...
Cell-Based Potency Assays for QC: Considerations for Development and Analytical Transfer
BEBPA 2018 -- Potency is the only critical quality attribute (CQA) that can demonstrate biological function. The potency assay must be relevant to the intended mechanism of action (MOA) and relate to clinical response where possible. Potency assays are notoriously difficult to develop and transfer and require considerable expertise and understanding to both perform and troubleshoot. Advanced Therapeutic Medicinal Products (ATMPs) add another level of complexity over that of large molecule...
Validation of Alzheimer's Biomarkers: β-amyloid 1-42 and Total Tau in CSF by Automated CLEIA on Lumipulse g 1200 Platform
CTAD 2018 -- Guideline for Alzheimer's disease diagnosis (AD) suggests using AD biomarkers for the pre-symptomatic and symptomatic phases. Cerebrospinal fluid (CSF) level of β-amyloid 1-42 (Aβ-42) and total Tau proteins have been increasingly included in the diagnostic process of Alzheimer's disease. Aβ-42 is cleaved from amyloid precursor protein that ends up as aggregates in the brain, Aβ-42 plaque depositions are widely used to characterize AD. Analysis of Aβ-42 in CSF of AD patients...