ABOUT CMED CLINICAL RESEARCH SERVICES

Cmed is Where Technology Meets Expertise. No other CRO is better prepared to support Biotech and Biopharma sponsors deliver the future of clinical trials. 

Technology-led, user-focused and with specialty expertise in oncology, cell & gene therapy, rare diseases, data science and analytics, we pioneered the processes for delivering next generation trials. 

As the global pharmaceutical industry continues to undergo seismic change, our 20 years of innovation, commitment and expertise enables us to embrace radical disruption and transform the clinical trials landscape for the benefit of patients. 

We anticipate. We adapt. We embrace every challenge. We are where you want to be.

FEATURED ARTICLES

  • This white paper highlights the key principles set forth in E8(R1), which was endorsed in May, 2019, and E6(R3), which is scheduled for publication in late 2022, illustrating how Sponsors and Contract Research Organizations (CROs) can achieve compliance. Cmed has been operating at the highest clinical research standards for over 20 years.

  • Download the available case study to read about a first-in-human, Phase I/II Study ofan Antibody-Drug Conjugate in Patients with Advanced Solid Breast Cancer Tumors.

  • The only widely accepted treatment fro Primary biliary cholangitis (PBC) is Ursodeoxycholic Acid (UDCA), which can delay disease progression and improve long-term survival but does not address the underlying disease. A solution provider drew on their expertise to contribute to the study design and selection of appropriate endpoints for a Phase II trial with a European Pharmaceutical company. Operational teams were then able to focus on data capture and cleaning, leading to safety review assessments, as well as a key Interim analysis, final analysis and clinical study report – all delivered on budget and within required timelines.

  • A Phase II trial with a U.S. Pharmaceutical company involving pediatric patients with selected inherited metabolic disorders undergoing stem cell transplantation is aiming to magnify the necessary cell population within a Umbilical Cord Blood (UCB) to quicken the time to reach transplant effectiveness and ultimately aims to positively impact the transplant success and survival rate. Partnering with a solution provider on enrollment, supply and medical monitoring is building a path to success.

  • A Phase I first in human trial with a European biotechnology company is being initiated using an adeno-associated viral vector (AAV)-based gene therapy. Complex studies such as this have challenges in both the set-up and execution phases, for this study in particular there are challenges to do with a gene therapy in a rare disease, and those revolving around the production, delivery and administration of radiopharmaceutical products as an assessment tool. Innovative solutions enabled sites to take part and to ensure trial is conducted successfully.

  • There is a tendency for Sponsors to view data management and analysis as a commodity business – something that one Contract Research Organization (CRO) can do as well as another. But the truth is, it demands a level of expertise and attention that is not always available in CROs for whom it is not the core component and specialty of their business.

  • The moment you decide that a clinical program needs to be conducted, stand back and think about the end of the program. How are you going to collect and assemble the consolidated clinical trial data so that it meets or exceeds the expectations of your eventual customer - a regulator, prospective licensing partner or investor? This article looks at the answer to this question by comparing outsourcing models and making some practical suggestions regarding CRO partner utilization and strategy.

  • A top 5 Pharma company was collecting data for a global disease registry from over 10,000 patients. To avoid collecting “free text” they wanted the study sites to use extensive “pick lists”. These lists consisted of over 12,000 unique options so could not be just simple lists. Cmed was able to provide a solution that would enable site staff to review, filter and select the required option.

  • A biopharmaceutical company had a first-in-human study in patients with solid tumors. They were in need of regular and timely reports to provied to the Safety Review Committee for dose decisions, to support rapid study completion. Cmed offered a solution by building an encapsia database to enable the sites to quickly enter their data and developed a robust and flexible set of programs to generate outputs required by the Safety Review Committee.

  • A biopharmaceutical company had an ongoing observational study with 120 patients in 5 sites. As the team started to plan their first Phase I study they realised that they wanted to align the data structures from both studies. By applying previous experience of rescue approaches for clinical data, Cmed built an encapsia database to meet needs for all prospective data.

  • A biopharmaceutical company had a Phase II study with 300 patients in 5 countries. At a key point in the study each patient’s treatment path depended on a score calculated from data collected over the previous period. Cmed was able to provide them with a solution that would enforce a workflow to ensure the accuracy of the data used in the score calculation.

  • Over the past decade, our neurologists, oncologists and clinical team experienced firsthand shifts in this research space. We understand the specific challenges in treating and researching this population and apply our medical and operational expertise when designing and implementing glioblastoma trials. Here is how we are applying our 20 years’ oncology trial experience to help find new therapies.

  • Clinical trials in rare diseases can be difficult to run due to a lack of patients, complicated study designs and challenging logistics; all of the above imply involvement of numerous countries, many sites and lengthy timelines to completion. However when you have the required expertise; studies in rare diseases are collaborative, innovative and perhaps some of the most rewarding for those of us having the chance to contribute to this research. It’s clear that what is essential to success is ensuring there is the right clinical team in place.

  • The COVID-19 pandemic has exacerbated the usual factors that can impact the start of clinical trials, including the need for the right study design, patient recruitment, appropriate inclusion/exclusion criteria, commercial/risk concerns and compliance with international regulatory constraints. Our clinical operations team have pulled together useful ideas to reduce startup delays that they have gleaned from over 57 hematology-oncology trials with pediatric, adult and elderly populations.

  • Radiopharmaceutical (RP) studies are not your average clinical trial. With the RP space expanding, sponsors need a team with the experience it takes to turn their synopsis into a fully rounded protocol with the maximum chance of success.

  • When planning a clinical trial it’s common for sponsors to overlook or underestimate the possibility of protocol amendments. The COVID-19 outbreak has shown the inflexibilities of much of the clinical trials industry. Read how having a CRO that can remain focused on being agile and flexible can minimize the impact of protocol amendments on your trial.

  • Deliberate flexibility in program and project planning allows trials to excel in areas like regulatory submission and approvals, enrollment and retention, and data review. Simple language adjustments to the protocol, intelligent use of decentralized services and real time data visibility via intuitive technology like encapsia can reduce project timelines by weeks or even months.

  • In this article we explore the value of taking a fresh approach to clinical data management and its associated systems – and ultimately the processes and roles that surround them. With the right technologies in place, companies can re-invent the traditional roles of Clinical Research Associates (CRAs) and Data Managers to reduce trial costs and timelines.