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Expertise You Can Trust
I am very lucky to have worked with Lucy on several studies, and to have been on the same management team in my prior work life. She is one of my most trusted DM resources. Lucy is thoughtful and efficient in her approach to every study and situation, and thinks outside the box to problem solve. She is an excellent communicator and acts in the best interest of her clients. Lucy considers the whole picture in order to execute a quality study: from the smallest technical details of a database build, how a query will be received by a site, to whether the data will be presentable in an acceptable way that is fit for purpose. As anyone who has worked with Lucy will attest, you cannot go wrong with having Lucy as a key member of your team.
Knowledgeable and expert DM
I have worked with Carol Coppock for over 13 years at Synteract, a CRO in Carlsbad, CA. I have found her to be a a highly competent Data Manager. She has worked on many challenging studies and has shown an ability to quickly review a protocol, assess the needs of the study design and is able to implement the designs into action. She has a high attention to detail, understands and executes database design according to CDISC/CDASH standards, has excellent communication skills and has built strong relationships with her Sponsors as a result of these traits. In particular, I remember when we were working on a study that had many visit schedules and varying paths the subject could take depending on results at different milestones within the trial. Carol was able to ensure that we had the appropriate checks and form structure in place to account for all of the possible scenarios that could occur throughout the study and challenged the team with possible outcomes that we had not accounted for. Through this process she would work through and make updates to help mitigate risks. This led to a successful foundation for the study to proceed. Carol not only understands the critical aspects of the design of a study but the varying aspects of the needs throughout the life of the study through to database lock and beyond. I highly recommend Carol for any Data Management needs and would jump at the chance to work with her again.
Top Notch Service and Results
I’ve worked directly with both Lucy and Vince for over a decade in the clinical research space. I can highly recommend their services to any small or large size biotech company looking for a team that can deliver quality on time and within budget.
Our Data Management Unicorn
Lucy has been absolutely essential to our company’s ability to deploy 8 oncology EDC systems in Medrio, including a Phase 3 pivotal trial and a first-in-human single-patient program, in under 13 months. We’re definitely not a fit-the-box kind of company and in terms of process development and improvement, Lucy is a fundamental piece of our program. She has a wide range of knowledge and experience, and her input has allowed us to exercise the requisite creativity while also sticking to the fundamentals of compliance and good practice with our data collection processes.
She is a full-service expert in all data management phases: in addition to supporting all of the steps of database initiation (including design recommendations and full UAT), maintenance, and closure processes, Lucy has drafted all of our database-oriented supporting documents. She has always been extremely accessible to our team, and accommodating of our ambitious company goals and timelines. Lucy’s willingness and ability to shift priorities and focus, while keeping track of the outstanding to-do lists for each project, is invaluable.
Carol recently joined our team as well, and has already provided extremely valuable recommendations on handling unique data management challenges in our randomized trial EDC systems. She is clearly very hands-on, and we are excited to have her working on our projects.
Integrated Team Support
Lucy has been a terrific partner providing valuable support and insight to our team. She has brought her extensive knowledge and experience to our team, ensuring our internal data management activities are fully compliant through all phases of development. We’ve been fortunate to have been working with Lucy for the past several years.
Great Problem Solver | True Collaborator
Over the years, I’ve collaborated with Vince on multiple clinical system implementation and validation projects. Vince is a skilled problem solver, with an eye for detail and effective risk mitigation strategies. His past expertise makes him an effective technical subject-matter-expert, but he is also exceptionally well suited for forward-looking analysis and leveraging new technology. One thing that separates Vince is his hands-on approach and ability to breakdown a complex project into assignable tasks. Vince is a good strategic planner but can also roll up his sleeves and perform at the tactical level, whether it’s configuring workflows or planning system access. Additionally, Vince is a pleasure to work with, a true collaborator at heart who continually strives for excellence.
Epitome of Knowledge and Focus
I have worked with Carol on few of our Studies in EDC and DM activities. Whether Carol was leading the study directly or helping the other study team, she is very well aware of the clinical study design parameters, the overall best practices and most important of all the customers’ needs. Carol’s mild manner but firm attitude helped us resolve some very tricky situations in a smooth and amicable manner. Carol is the epitome of Knowledge and possess undeniably strong focus to lead most complex studies be they are by design or thru practice. Carol at the lead, one can easily relax knowing the finished study is not simply what you asked for but sure to be a long-term tenable product with all the best practices.
Lucy Spencer is the “go-to” person for data management. Lucy and I began our work relationship 14 years ago when I joined Kosan Biosciences as Senior Clinical Research Associate responsible for managing clinical trials. Lucy was instrumental in managing the data entry and providing output analysis for several concurrent trials. Efficiency, dedication, forethought, reliability are her work ethics which provide quality outcome. Consistently through trial after trial her data management skills have excelled – on time and on budget with her characteristic pleasant genuine personality. Lucy is my definite choice when searching for a quality data management resource.
Skill and Expertise
I have worked with Lucy for over 15 years and I trust her data management skill and expertise. Her experience ranges from study start up through post database close. She can use various EDCs but is versed in Medidata Rave using her certified study builder/administrator to provide an expert level point of view in assessing database design/configuration, identifying risks and providing solutions. I recommend using Insight Clinical Consulting services for all data management needs.
I had the pleasure of working with Carol on multiple studies during my first year with the company. Carol was so amazing to work with. She was knowledgeable in all aspects of her job from EDC build, to DM SOP’s, to knowing industry standards and best practices. She produced quality work every time, on time, which gave our clients peace of mind that we were a team that could be counted on. Our clients loved working with Carol and I believe she had a big hand in getting repeat work from them as well as them allowing Synteract to expand our services with their contracts. She was a fantastic leader in the DM group and she takes great ownership in her work. Anyone that gets the opportunity to work with Carol will be in good hands for sure!