Read what some of our clients say about working with Clinipace:
Kip Vought , VP Global Devlp, SCILEX Pharmaceuticals, Inc.
I wanted to say that CPWW was at the top of their game through the whole process of our recent NDA submission. This effort was critical for Scilex and Sorrento, and CPWW played a critical role in designing/executing studies and getting this to FDA. What is most impressive is that the folks just took ownership to make this a success.
There were several times that we relied on the intellect and hard work of the RSD team to get us through tough issues. In that regard, we want to give Kelly and Emileigh special recognition – they were instrumental in determining our regulatory strategies and study designs. That was especially important given the complexity of the issues we were facing.
The Regulatory Operations folks stepped up nicely and took it upon themselves to ensure we met our timelines. They did so with no compromise in quality of the documents, and they have the highest quality I’ve seen.”
Vice President, Global Development,
SCILEX Pharmaceuticals, Inc.
Daniela Reichhardt, Bavarian Nordic GmbH
“Clinipace managed a full service Phase I trial in normal, healthy volunteers to evaluate the safety, tolerability, and immunogenicity of the recombinant MVA-BN® RSV vaccine and ensured the study timeline was met. Each cohort was enrolled on schedule, and all data cleaning activities and on-site monitoring was completed throughout the study as each cohort finished, resulting in an efficient database lock. It was a pleasure working with Clinipace on this trial. Clinipace gave us a smooth CSR preparation process.”
Senior Clinical Project Leader, Bavarian Nordic GmbH
Christa Lee, AbbVie, Inc.
“I just wanted to reach out to you and tell you how pleased I am with the randomization progress since we implemented the leads calling the sites either with subjects approaching day 60 or that had gone beyond day 60. We were averaging 9.7 rands/week in the two months previous to implementation. Not including today, our average has since risen to 12.5/week. If we continue to achieve the new average or better, the study should finish closer to our original goal of end of Feb 2014. A giant thank you to the team is in order, and if there are any additional weapons to add to our arsenal, please don’t hesitate to let us know. A huge round of congrats and back patting from the AbbVie team to Clinipace.”
Clinical Research Manager
Julian Howell, Phosphate Therapeutics Limited
“Given the gravity of the disease under study and the significant therapeutic promise shown by PT20 in early research, it was crucial for us to work with a provider that could help us complete this pivotal study quickly and effectively in order to reduce the development risk associated with the PT20 programme. We look forward to working with Clinipace on this important study.”
Group Medical Director, Phosphate Therapeutics Limited
Todd Butler, Prometheus
“Patient enrollment is one of the biggest challenges we face when starting an oncology trial; thus, it was critically important to team with a CRO we felt could provide oncology expertise along with a robust electronic data management platform. We will be able to monitor our studies to ensure they are on track right from the start, specifically, the number of patients enrolled at each of our sites, as well as factors that impact enrollment and protocol compliance. With the ability to monitor these critical areas in real-time, the study teams can adjust patient enrollment strategies with improved data quality.”
Director of Clinical Operations, Prometheus
Julie Gavigan, AbbVie, Inc.
“I just wanted to drop you a line to let you know that I appreciated the hotel accommodations, warm welcome, great meeting, delicious food and outstanding company during our face to face meeting last week. I know a lot of time and effort went into scheduling and setting this up. You took this study when we were knee deep in…… and are responsible for the success that we have had with the Pivotal 1 study. We couldn’t have done it without you, and we continue to have success daily with the stellar team that we have been given to work with. You all are a pleasure to work with on a daily basis. You certainly make our jobs easier. I know Christa spoke to the success of our team and program, and I second her comments.”
Contract SR. CRA, AbbVie, Inc
Nova Silver, RN, Fortress Biotech
“Our study had complicated enrollment logistics that necessitated much involvement on Clinipace’s part for the first 28 days after informed consent. Within this time period, Clinipace successfully identified and verified patient eligibility; scheduled donors, laboratories, and apheresis collection; confirmed vendor processing and manufacture availability; and managed Investigational Product manufacture and QC release timelines. They also organized and tracked the product and shipping container outbound and return courier handling, ensuring everything was managed correctly and on time. We were lucky to be working with such a capable company during this complex enrollment.”
Nova Silver, RN
VP of Clinical Operations, Fortress Biotech
Fortune 500 Affiliate
“I worked with the Clinipace team in Brazil when I needed to hire quality monitoring services for a Phase IV study in Otolaryngology. The team was very professional during all the project steps. When new staff needed to be incorporated to the study team, the turnaround from Clinipace was very fast and did not compromise the study progress. I would definitely recommend partnership with them for clinical trial monitoring.”
Clinical Quality, Medical Affairs Manager
Fortune 500 Affiliate
Andrew Asimos, M.D., NC Collaborative Stroke Registry
“With Clinipace’s research software platform in use within the NCCSR, finding the right hospitals to participate in the study took minutes, not months. The reporting engine within TEMPO made patient recruitment straightforward and easy to manage. Clinipace allowed me to easily manage the project without creating a burden for our hospital sites and busy data collection team [given this wasn’t their primary job].
Utilizing TEMPO’s built-in workflow engine and reporting tools, we were able to automatically assign follow-up tasks and provide reminders to each stroke program coordinator. Since information was able to reach the research team in real-time, team members could quickly run reports [within their appropriate permissions] to keep up-to-speed on enrollment and follow-up milestones.
Having instant access to data made managing the project very easy. I was able to significantly reduce the time it would have taken to identify sites and eligible patients by mining the registry data. The collaborative nature of the relationship between NCCSR and Clinipace, as well as the software platform, flexible workflow processes, and real-time reporting, enabled the project team to complete the research phase in as little as 7.5 months. Without the collaboration, a similar project would have taken me 3 years. I would have never been able to do a project this ambitious within my budget without Clinipace.”
Andrew Asimos, M.D.
Site investigator, North Carolina Collaborative Stroke Registry
Independent Specialty Pharma Company
“I’m nearly finished at my last day at [Sponsor], and I wanted to thank you all for your great input on the study and especially at the KOM last week. I’m sure it’s going to be a great success with such a strong team behind it.”
Program Manager, Independent speciality pharmaceutical company
John Ely, On-X Life Technologies, Inc
“Not only was the cost reasonable, but they were also willing to offer flexibility in terms. Trials are expensive, and they understood our needs. The software deployed quickly, and the investigator sites love it. Several investigators have actually volunteered to tell us how well TEMPO works in managing the study. I’ve been in this industry a long time and this is the first tool I’ve seen with the flexibility we needed to manage our research processes.”
On-X Life Technologies, Inc