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We aim to keep you in the know. When we make changes, add services, announce partnerships, and/or get noticed in the press - you can read about it here.

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Everyone likes good press but 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.

For Immediate Release

Mohnton, PA, and Wayne, PA - June 2, 2021 WAYS Pharmaceutical Services, a leading provider of regulatory submission management services for life sciences teams, today announced a strategic partnership with TradeCraft Clinical Research, a leading provider of Statistical Programming and Biostatistics services for life sciences organizations. 

The alliance formalizes two years of cross-client collaborations. WAYS and TradeCraft have worked on numerous electronic regulatory submissions where WAYS provided submission management, compilation and publishing services and TradeCraft delivered CDISC-compliant data packages.

Matt Stroschein, WAYS CEO, noted, “The WAYS and TradeCraft teams have worked together throughout our careers. We understand the importance of having the right expertise on your team as you prepare for a regulatory submission. TradeCraft has the CDISC and data expertise that we look for in a partner and have come to rely on to ensure successful submissions for our customers.”

Mike Willis, TradeCraft CEO, added, “We are happy to formalize our partnership with WAYS. Regulatory submissions are complex and require specialized expertise. Our combined services offer a comprehensive solution, especially for small teams who need access to data expertise along with efficient submission management services.”

A key benefit of this partnership for customers is the increased access to best-of-breed services that target CDISC and eCTD compliance. 

About WAYS Pharmaceutical Services

WAYS Pharmaceutical Services delivers expert regulatory submission management services to life sciences teams that are preparing for or maintaining electronic regulatory submissions supporting drug, biologic, and medical device trials and marketing applications. The WAYS team combines collaboration, innovation, and commitment to provide quality electronic submissions and an unparalleled customer experience. No drama and no trauma - just solid expertise delivered where and when you need it.

Visit our website at www.waysps.com

About TradeCraft Clinical Research

TradeCraft Clinical Research is a life sciences consulting firm providing expertise in the Statistical Programming and Biostatistics disciplines to pharmaceutical and biotechnology companies. We specialize in the efficient development and creation of CDISC-compliant data packages for US FDA.

Visit our website at www.tradecraftclinical.com.

 

Ways and TradeCraft Announce Partnership:

Alliance Formalizes Collaborations

For Immediate Release

WAYNE, PA, USA and London, UK- May 18, 2021 – TradeCraft Clinical Research, a leading provider of Statistical Programming and Biostatistics services for the life sciences industry, today announced a new partnership with Green Room Life Sciences, based in London, UK. 

 

TradeCraft Clinical Research offers expert biostatistics and programming support, specializing in CDISC data packages for US FDA regulatory submissions. Green Room supplies life sciences business development and European market advisory services. Through the partnership, Green Room will introduce TradeCraft’s cost-effective, efficient, and reliable Statistical Programming and Biostatistics services to the European market. 

Mike Willis, TradeCraft CEO, noted, “We are excited to be expanding into the European market and thrilled to have Green Room Life Sciences partnering in this effort. This is a strategic initiative that will accelerate our growth goals and help TradeCraft connect with more life sciences teams, especially those who need our US data submission expertise.”

Jason Marks, CEO of Green Room Life Sciences, added, “TradeCraft has a wealth of experience developing CDISC compliant data packages that support US regulatory submissions. Many European life sciences companies need access to this type of expertise. I look forward to working with Mike and his team as we bring their services to the European audience.”

The alliance marries TradeCraft’s expert Clinical data services with Green Room’s industry knowledge and trusted positioning in the European market. Pharmaceutical, biotechnology, and medical device companies across Europe can contact Jason Marks to learn more about the partnership and TradeCraft Clinical Research services.

Jason Marks

CEO

Green Room Life Sciences 

+44 7970 677005

jason.marks@grls.co.uk

 

About TradeCraft Clinical Research

TradeCraft Clinical Research is a life sciences consulting firm providing expertise in the Statistical Programming and Biostatistics disciplines to pharmaceutical and biotechnology companies. We specialize in the efficient development and creation of CDISC-compliant data packages for US FDA.

Visit our website at www.tradecraftclinical.com.

 

About Green Room Life Sciences

Green Room Life Sciences is a specialty business development and consulting firm that delivers local expertise in assessing client needs and understanding complex business challenges. Green Room supports Life Sciences teams by connecting them to powerful solutions at every stage of the drug development lifecycle. 

Visit our website at www.greenroomlifesciences.com.

TradeCraft Clinical Research Announces Partnership with Green Room Life Sciences

Green Room to Drive Growth in EU Market

 
 
Image by Nastya Dulhiier

Complex Trials

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 an eight-week period.

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.

Ray

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.

Judy

Vice President of Clinical Operations 

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Effective Communication

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 a 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 work 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. 

Tom

Sr. VP, Development Operations

Expert Support

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

Image by Ruthson Zimmerman