Testimonials
Dr. Charles Abrams, Vice Chair for Research and Chief Scientific Officer, Department of Medicine:
Amanda and her incredible CTU Team are the entire package!!
From day one, they hit the ground running and never stopped. I was the PI on a multi-institutional trial, and Amanda offered sage counsel every step of the way. She drafted and implemented protocols, and worked closely with sites at many other academic institutions to efficiently and effectively drive enrollment. A special shout-out to Haideliza Soto-Calderon, who was truly exceptional. Haideliza without fail was always there to address all issues that arose. Lauren's diligence with regulatory work and site monitoring kept us compliant. I could not be more impressed and grateful to Amanda and the CTU team for their exceptional care, commitment and camaraderie.
Dr. Ebbing Lautenbach, Chief, Division of Infectious Diseases:
Amanda Baer and the CTU team are an amazing resource for the Department of Medicine. They are incredibly knowledgeable and have a tremendous amount of experience. They are there from start to finish helping to understand the needs and goals of the project, anticipating and identifying potential pitfalls along the way, devising strategies to resolve issues, developing ways to optimize study performance, and streamlining study finalization. The CTU is a particularly valuable resource for new PIs with less research experience looking to further develop this part of their careers. They are similarly valuable for more experienced PIs who have less time to be as hands-on for day to day details. Faculty can be fully assured that if they are working with the CTU, the work will get done, and it will be done well!
Krishna Kallem, Project Manager, Renal:
Department of Medicine’s Clinical Trial Unit (DOM CTU) is a wonderful resource to the research professionals at Penn and a great asset to advance Penn’s core mission of academic research. I had the wonderful opportunity to work with several people from the DOM CTU who not only supported our team on the regulatory, operational, and start-up aspects of clinical research, but also provided managerial support on several trials. Their experienced team was quick to learn the protocols and made an impact in a relatively short time period. DOM CTU’s vast research expertise combined with the ability to engage and bring the projects to fruition in a relatively short time frame, under the excellent supervision of Amanda Baer, is one of their greatest attributes. We have greatly benefited from Amanda’s mentorship and leadership guidance in the restructuring of our research group. In addition, their experienced staff provide training sessions on several research topics that are a great resource. I hope their initiatives and continued growth will set standards for a unified experience to both the internal and external stakeholders of clinical research at Penn Medicine.
Maria Caturla, Associate Director of Regulatory Affairs, Penn Office of Clinical Research:
I have been working with the Clinical Trials Unit for the past two years and it's been a great experience. They are reliable, hard working and very knowledgeable in the field. The team is always available to answer any questions or provide support when needed. They are also very accommodating to research needs and have been able to adapt quickly to any changes in the clinical trial process. I highly recommend the Clinical Trials Unit to anyone looking for a reliable and professional team to handle their clinical trial needs.
Dr. Andrea Apter, Professor Emerita of Medicine, Allergy & Immunology:
Amanda Baer and the CTU team are wonderful and an essential resource to the Department of Medicine. During the COVID pandemic, our NIH-funded intervention study for low-income adults with asthma was struggling, because two out of four research coordinators could not work because of COVID-related issues. Amanda and her team stepped in and provided necessary data collection skills, which allowed our team to keep functioning and succeed. In all clinical research, events happen which threaten the operations of the research teams. The CTU is an essential resource for these situations. The CTU also has been essential in helping a new clinical research project in Allergy and Immunology get started, when the investigators had never been part of such a research team previously. Amanda and the CTU provided and organized the research coordinator team.
William Ferrell, Project Manager, Department of Medical Ethics & Health Policy:
I have had the pleasure of working with the CTU on two projects in the past two years. In my experience, the staff support we have acquired via CTU has been exceptional. Katherine and Joelle (CRCs) each displayed professionalism and their quality of work was superb throughout. Amanda Baer is responsive and flexible when I inquired about staffing options. Overall a great resource at Penn that I will continue to lean on in the future!
Dr. Staci Kallish, Medical Genetics:
The CTU team has been an essential resource. From the initial inquiry and feasibility assessment, through protocol review, budget development, and IRB submission, and then to the study itself with study coordinators, the team is efficient, energetic, and professional. As a newer investigator, the CTU team has been able to guide me through this process with their extensive experience. I’ve had the opportunity specifically to work with Haideliza as a project manager on both existing studies and on starting new studies – she and her team are amazing!
Dr. Peter Merkel, Chief of Rheumatology:
Pros:
- Flexible
- Reliable
- Friendly
- Scalable (pay only for time you use)
- Quality work
Cons:
- What if everyone finds out about these folks?
Ms. Baer and her whole team took the time to understand our research projects in detail, addressed acute and ongoing needs ranging from data entry to regulatory documentation to patient interaction, all in a professional manner with accountability, oversight, and flexibility, and all work was conducted at a reasonable cost. Multiple investigators in our Division have each had excellent experiences with the CTU. This is an important service that nicely addresses a longstanding unmet need for substitute and/or part-time clinical research staff.
Dr. Daniel Rader, Chief of Translational Medicine & Human Genetics:
Amanda Baer and her team in the CTU are simply amazing. With her extensive experience in navigating the journey from concept to active clinical trial, Amanda gets the gold medal for both speed and style. I’ve had several experiences of asking Amanda to lead the launch of a new trial and she and her team have done literally everything, from developing the budget to shepherding the contract to ensuring efficient IRB review and approval. In the situations in which I’ve also needed support of her project managers and coordinators, they’ve been professional and terrific to work with. For a busy PI who wants to be actively engaged in interesting clinical trials but doesn’t have the time, expertise, or personnel to take care of all of the details, the CTU is the obvious solution. My biggest concern is what will happen when everyone knows about the CTU!
Dr. Emma Meagher, Vice Dean and Chief Clinical Research Officer, PSOM:
Investigator-initiated clinical trials are complex to initiate and execute effectively and efficiently. Having expertise, such as that provided by DOM central, on your team can be the ace in your back pocket.
Dr. Jonathan Hogan, Associate Professor of Medicine, Renal:
You guys are doing all the hard work and I really appreciate it. But this is exactly why we need your expertise on these things -- there is no way I would be able to devote the time to do this, which creates [a] missed opportunity for Penn researchers.
Dr. David Fajgenbaum, Assistant Professor of Medicine, Immunology:
I had the opportunity to work with Amanda and Tracey from Clinical Research Operation on an R01 submission. They were incredibly helpful with thinking through important strategic and operational questions related to the proposed clinical trial in Specific Aim 3 and the grant budget. With their support, the R01 received a fundable score and it should be funded [soon]. I look forward to working with Amanda and Tracey to execute this exciting project.
Dr. Mark Osterman, Associate Professor of Medicine, Gastroenterology:
CTU has been awesome to me. Your team is incredibly competent and efficient. You guys have helped me get a number of new trials started and have also helped my coordinator on my ongoing trials. Without you guys, I definitely would be behind in my current trials and would not have been able to take on others.
Dr. Jacob Brenner, Assistant Professor of Medicine, Pulmonary:
The CTU is a truly incredible resource that has helped push forward medical device research at Penn. For an investigational medical device my research team is building, the CTU created our entire clinical testing program, from writing the IRB protocol, to enrolling patients, to conducting the clinical studies themselves. Amanda Baer is a terrific leader of the program, and very easy to work with. Our study has been run by the CTU’s Haideliza Soto-Calderon, who is absolutely spectacular and has become an integral and passionate member of our team.
David Zuzick, FH Foundation:
Our study design is complex and is further complicated by the involvement of multiple sites. Overall, I’ve been very impressed with the level of project management and tracking status. Most clinical studies will encounter unexpected events or issues (e.g., medical leave, vendor quality issues, etc.). I’ve been pleased with the team’s responsiveness including timeliness to resolve [issues] and [make] sure that the appropriate organizational resources were brought to bear. The team is working in a very “boundaryless” manner — great teamwork with the sponsor, additional clinical site, vendors (e.g., genetic testing), and other subject matter experts (e.g., genetic counselor).
Rebecca Helgesen, Administrative & Financial Officer, Penn Genetics:
The CTU has provided critical support to our Division both with projects they have managed from inception and with ad hoc issues that have required a high level of expertise. Amanda and Tracey are expert in all facets of clinical trial management. In spite of a high demand on their time they have been very flexible and responsive, and they are wonderful to work with. I am grateful!
Shira Blady, Project Manager, Renal:
My honest opinion of the CTU is that the group and the individual people have been wonderful to work with. Both Esther and Maria were always willing to help, no matter what we needed, and they provided excellent work. Having the CTU available as a resource is beneficial across the Penn Medicine research community. Knowing that if a study needs assistance, whether it is to help get started or to fill in for staffing shortages, makes overcoming obstacles more attainable and helps make all of the research studies at Penn more successful. I believe that the CTU should continue to grow and become a foundational resource for the Penn Medicine research community. Having a strong CTU group benefits not only the researchers and staff, but the patient community as well, allowing us to provide the best research services we can.
Diane Pinder, Project Manager, Pulmonary:
This team is professional, detail-oriented, kind and extremely capable. We used their services to help cover us when I was on maternity leave. Our pulmonary research team is a well-oiled machine so we had some reservations having someone from the outside come in for the assist. I should never have doubted them! We were very pleased on how quickly they were able to pick up on the protocols and execute the studies as needed.
Victoria Fleck, Clinical Research Program Manager, Advanced Lung Disease:
I utilized the CTU for regulatory start up on two industry clinical trials and have been very happy with the quality and promptness of the work. The regulatory specialist handled everything – I only had to approve documents prior to submission and answer any relevant questions she had. I preferred utilizing the CTU service over other temporary staffing options, as I did not have to do any onboarding and the CTU team members are all familiar with Penn platforms and entities such as HS-ERA, CACTIS, OCR, etc.
Clinical Research Team, Penn Division of Rheumatology:
We have been fortunate to work alongside the CTU team on both investigator-initiated clinical trials as well as industry-sponsored studies. Through our experiences, we have found the CTU team to be exceptionally knowledgeable and highly experienced with working on clinical trials. Amanda, Tracey, and their team have helped us adopt clinical research best practices which have translated to improved performance during internal audits and external monitoring visits. Their professionalism is exemplified in how their staff is able to seamlessly integrate themselves into existing studies and make significant contributions towards the success of the study. Additionally, the CTU team is friendly and personable and simply a joy to work alongside. We truly believe that the CTU team is an asset to the Penn clinical research community.
Dr. Jessica Wilson, Instructor in Medicine, Endocrinology:
The CTU is a unique resource at Penn that streamlines the execution of clinical trials and patient-oriented research. I have been thoroughly impressed with the expertise and professionalism of Amanda and her team. They are consistently organized, timely, and hard-working. As anyone who has experience in patient-oriented research knows, subject recruitment can be challenging. Amanda and her team were able to effectively find solutions to identify and recruit volunteers for a study with restrictive inclusion/exclusion criteria. The study would not have been successful without their ingenuity, ability to quickly adapt, and mastery of knowledge about clinical trials flow.
Dr. Daniel Soffer, Clinical Associate of Medicine, Cardiology:
Amanda Baer and her group have been a terrific resource. While our group has maintained specific research teams independently, her team is our primary resource and has even chipped in when piecemeal projects need to be accomplished.