INSIGHTS ON CLINICAL TRIAL PARTNERING
The Sunsetting Of Rare Pediatric Disease Designation
As with other incentive programs, FDA created the Rare Pediatric Disease (RPD) designation to encourage drug development in products with questionable financial viability. As things currently stand, FDA is sunsetting the program, and may not award priority review vouchers for any product unless the product has received RPD designation by September 30, 2020. How can a sponsor increase the chances of a favorable first round review with such a short window of time remaining?
Improving Regulatory And Operational Performance In Orphan Drug Development
The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.
Five Easy Investigator Payment Fixes To Improve Site Relations
Site satisfaction is closely linked to the frequency, accuracy and timeliness of clinical trial payments. Yet making payments has long been a challenging process between sponsors and sites. This white paper reviews five common issues that delay site payments and offers recommendations to resolve these issues, improving payment efficiencies and ultimately site satisfaction.
Removing Barriers To Specialty Therapies
Gaining access to specialty medications requires navigating multiple complex pathways, including determining insurance coverage options, co-pay amounts, the patient’s total cost of therapy, prior authorizations, and appeals. Obstacles along each path can lead to increased turnaround time and drive script abandonment. Technology brings advancements for removing these barriers, but buyer beware.
Best Practices In Site Feasibility Studies Can Set the Stage For A Healthy Trial
Well-performed site feasibility can become the single most important factor in reducing costs and time spent in a clinical trial. With adoption of benchmarking and clinical trial tools, sponsors are able to know exactly how many sites they need in their trial, which makes site pre-identification essential for efficient study start-up.
A Day In The Life Of A CRA During COVID-19: An Interview With Raquel Telfer
Raquel Telfer, Senior Clinical Research Associate at Rho, has been in the clinical research industry for over 10 years. In this blog she speaks candidly about her experience as a CRA, provides examples of how the clinical landscape is evolving for CRAs and patients, and how she finds energy and inspiration during these unsettling times
How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity, And Risk
Clinical trials are conducted according to a protocol, which is the master action plan for how the study will be conducted. Clinical trial protocol design can have a significant impact on the sourcing strategy for commercial drug products used as comparators. View the article to learn how proper planning, effective communication with specialized experts, and providing the appropriate level of detail in the clinical trial protocol can help avoid subsequent sourcing issues and can minimize the need for protocol amendments
Local Lab Normalization
Local laboratory data normalization is a routine process in clinical trial data management. However, even with standardized collection and transport procedures across the laboratories there is often variability to account for. This paper highlights the modern need for access to local laboratory data in near real time.
Considerations For Implementing Decentralized Clinical Trials
Our teams have helped many sponsors navigate and implement decentralized solutions for their clinical trials and programs. This includes providing recommendations for the level of decentralization required (e.g. a fully virtual trial or a hybrid approach), as well as the development of strategic plans for remote and central monitoring, technology integration, IP management, and site and patient engagement. In this blog we discuss some considerations for successfully implementing decentralized solutions.
CLINICAL TRIAL PARTNERING SOLUTIONS
End-To-End Oncology Development
Pioneers developing the latest targeted therapies turn here for innovation and expertise. We’ve conducted over 155 trials across numerous indications in the past five years.
Clinical Trial Project Management
LabConnect’s project managers are passionate about clinical research and dedicated to ensuring the success of your project. Our experience allows us to design better laboratory services to meet the needs of your investigative sites while identifying and managing risks in the project.
From Trial Design To CDISC Submission
CRO manages multiple, complex statistical analysis deliverables for a program of studies, CDISC compliant outputs, and data pooling for NDA submission to the FDA with minimal sponsor oversight.
Providing Uncommon Expertise For Your Oncology Program
Worldwide Clinical Trials' award-winning, specialized early phase oncology team helps emerging and established biopharma, biotech, and pharmaceutical companies accelerate the advancement of early phase compounds through clinical testing.
Promoting excellence in clinical research
At Rho, Quality Assurance (QA) is an independent group that promotes excellence by ensuring adherence to our processes, applicable regulations, and Good Clinical Practices (GCP). Our auditors’ focus on quality has been honed by years of multidisciplinary clinical research training, from extensive education on topics from software validation to GCP to FDA requirements.