MD&D Success

We are currently recruiting an orthopedic device study and believe that we may complete recruitment up to six weeks sooner than predicted. This is mainly due to the careful site selection. In terms of maintaining quality, it has been important that we have flexibility in the contract in terms of the number and frequency of monitoring visits, and that the data capture system being employed is electronic.

A number of our clients have expressed how well Pleiad performed on their projects and we share some of these comments with you here.

"I wanted to thank you for a job well done on the XXX CER. We just had our audit meeting with TUV and they specifically mentioned that the literature review process was "best in class". I appreciate your efforts to get this done in a short time, especially given the unique and challenging nature of this type of device report. TUV said that the process of including/excluding data was very clear, and the analysis of the findings was very descriptive and complete. One small note they made during the audit was to consider including a specific section called "justification for literature route". While TUV agreed that this information was there, it might be clearer if it had a sub heading as such. With that, it would be absolute perfection! The auditor said it will change the way he looks at these documents, and has raised the bar for his expectations of what a CER should include. Kudos to you. Thank you."

Manager of Clinical Affairs, Vascular Division of Major Medical Device Company

"I would like to thank the staff at Pleiad for managing the study this past year. We appreciate your CRO expertise and are pleased that you were able to assume your role in the midst of the difficult ongoing study. With your help we successfully retrieved the available data and brought the study to a close. It was a pleasure working with Pleiad and we look forward to working with you again on another project."

Clinical Project Manager, Therapeutic Device Company

"Outsourcing clinical services is a cost effective approach for medical device companies and enables them to access a wide range of skills. We assessed a number of contract research organizations and selected Pleiad as our preferred provider of clinical research services. This was based on Pleiad's expertise in running clinical trials for medical device companies and their flexible and proactive approach to product development and commercialization. They provide valuable support to our clinical, regulatory and commercial teams."

Managing Director, Tissue Ablation Company

"We chose Pleiad, after a thorough audit, to assist us with a monitoring resource shortfall because they were responsive, flexible and knowledgeable. They were able to come on board at short notice and work effectively in sometimes difficult circumstances. We would definitely consider them for future clinical research projects."

Clinical Research Manager, Orthopaedic Implants Company

"Pleiad helped design clinical studies for our novel laryngoscope devices. They have also worked with us to scope out the potential market for this device in Europe and the USA. We have found their flexible and supportive approach extremely valuable. We now interact with Pleiad on an ad hoc basis to obtain advice on all things clinical, as we move through the commercialization phase for our Series 5 laryngoscope device."

CEO, Trauma & Surgical Equipment Company

"Pleiad supplied our company with high-quality and professional clinical assistance and worked in close partnership during key phases of our device development program. They successfully achieved a key project objective, which was to demonstrate the clinical applicability of our new technology and to assess that new technology in relation to existing devices. Specifically, Pleiad's independent clinical expertise was able to generate a scientifically objective report by applying an evidenced-based analysis to hundreds of medical publications. The overall quality and thoroughness of the final clinical literature review supplied to us was excellent."

Project Leader, Tissue Ablation Company

"Our company is commercializing a novel endovascular device. We needed to access opinion leaders in North America and Europe in order to assess the device's potential attractiveness and to obtain input on its design. Pleiad helped us to find the right people to talk to and to formulate the appropriate questions. They facilitated the meetings and wrote the market assessment report that was provided to our investors."

CEO, Endovascular Company