Our clients are our top priority. We know we are doing well when they reach out with appreciation and accolades. We want you to feel the same way about your projects that our clients feel about the projects that we do for them.
Empowered Expert Leadership
My organization’s engagement with Tradecraft began with a limited scale of submission activities, namely an ISS comprised of two completed trials and a Phase 3 pivotal trial that was still enrolling. Facing some already challenging overall submission timelines, absorbing some key shifts in scope, and in assessing capabilities amongst our vendor landscape at that time, it became clear that we needed much more.
Tradecraft stepped up and not only filled a significant void with just-in-time, quality resources but played a major role in helping advise us. This included re-defining some key milestones and timings to get us back on track, as well as taking on a much broader scope of work. This included an expansion of services that grew over the next several months to include:
Gap Analysis/Clinical Data Asset Review for 16 trials, which included
SDTM/ADaM specification reviews,
Reviews of Pinnacle 21 reports, Defines, and Data Reviewer Guides produced by other vendors for completeness and consistency
Study Data Standardization Plans,
ISS that also changed in scope and increased the number of studies included,
Legacy data mapping for 7 studies,
Prospective/live study DTLFs for 4 studies,
BIMO for 3 studies,
Pivotal Phase 3 results confirmation
Simply put, Tradecraft epitomizes excellence in our industry. With each major shift or minor tweak in our submission planning efforts, their expertise, proactive approach, and high level of ownership made a huge difference and were tremendously important in positioning our organization for success.
Head of Biometrics
We engaged TradeCraft Clinical Research on a complex trial where they were joining the team rather late in the process. They jumped right in and collaborated with our team and our CRO. This particular trial involved patient-entered data being collected from a mobile device.
TradeCraft worked with the CRO to develop ADaM specifications within four weeks. They designed detailed programming handling guidelines to address data quality issues and generated compliant TLFs. They succeeded in delivering over 290 compliant outputs within eight weeks.
Based on issues identified in this process, they again surpassed expectations by voluntarily taking the lead in validating the primary efficacy analysis dataset. We were impressed by their responsive, collaborative approach and their commitment to the success of our project.
Chief Operating Officer
ADaM, SDTM, TLF (Phase III)
I initially started working with the TradeCraft team when we asked them to validate the TLF output from another CRO for three Phase II trials. TradeCraft collaborated with the CRO’s offshore team throughout the project. The validation work ended up being substantially more than originally expected. TradeCraft also created compliant production output that the CRO was unable to provide.
In later projects, TradeCraft handled a variety of different projects for us:
Created Annual Safety Reports for 9 clinical trials
Created SDTM, ADaM, and TLF output for 10 trials
Created Study Data Standardization Plans for three Phase II and three Phase III trials
Created the SAP for an ISS/ISE
More recently, we had a unique requirement for a custom macro that would programmatically compare the discrepancy status of certain files and track vendor and sponsor comments. TradeCraft understood our requirements for ad hoc reporting and quickly designed and generated the detailed macro so we could use it in our ongoing project. The macro eliminated a large manual effort to compare different versions of files. It saved a great deal of time as we finalized our data packages for submission. Their expertise and innovation helped our team deliver compliant output while meeting some aggressive timelines.
Vice President of Clinical Operations
We are a small, late-stage biotechnology company with approximately 90 employees. I am responsible for Strategic and Product Development in the company. Our company works primarily in an outsourced model for the majority of our activities. I had the opportunity to work with TradeCraft Clinical on a high-profile, top-priority project with an aggressive timeline. Mike and his team provided programming oversight and support to prepare an integrated summary of safety as well as output for several supportive studies which were part of an MAA submission. Mike and his team were professional, knowledgeable, and produced a high-quality work product. They met timelines and deliverables and on occasion exceeded them. They worked collaboratively and effectively communicated on a regular and ongoing basis throughout the project’s lifecycle. I would use Mike and his team in the future and would highly recommend them.
Sr. VP, Development Operations
TradeCraft has been an invaluable partner to Advaxis for several years now. They have become a true extension of our group by getting to know all of our programs in detail and by providing robust standardized data analyses for academic and regulatory submissions every single time. The flexibility to have an expert group readily available to support us in a fast-paced biotech environment has been crucial to our success. I highly recommend you to give them a call.
Andres, M.D. Ph.D.
Chief Medical Officer - EVP