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Company Overview Pearl Pathways is obsessed with accelerating life science product development for our clients. We are an extension of our clients’ teams. We partner with the clinical team, in-house regulatory experts, the quality compliance specialists, the quality auditors, and the senior leadership team to get lifesaving diagnostics and therapeutics on the market sooner. Our talented staff is focused on getting critical research done, ensuring high quality and efficient manufacturing of products, accelerating global product registrations, and keeping our clients up to date on current regulatory and quality compliance best practices for life science product development. Pearl IRB: Protecting human subjects and driving improved value and efficiency in protocol reviews and study implementation Pearl ReGXP: Providing regulatory & quality consulting, and auditing services Pearl IDEAS: Offering strategic product development assistance through our life science consulting practice 29 E McCarty Street, Suite 100 Indianapolis, IN 317.899.9341 ph 317.602.6554 fax www.pearlpathways.com www.pearlirb.com Situation: A startup biopharmaceutical company asked Pearl for assistance with medical writing to prepare for needed publications in support of an upcoming IND approval and launch. The client required assistance composing several pharmacokinetics publications, abstracts and posters. Solution: Pearl provided a team of medical writers to help the company for 4 months producing a total of 8 publications and 8 abstracts/posters. Pearl led all medical writing activities and worked across a cross functional team at the client to project manage the project including efforts to secure needed references and raw data. Pearl also worked to ensure all publications met journal publishing requirements. Result: Pearl worked closely with the client team, and provided high quality draft publications, abstracts and posters. As a result of Pearl’s work, the client exceeded project deadlines, and was extremely pleased with the quality of the writing, and is currently seeking further work with Pearl. Medical Writing Client: Biopharma Startup Client

Pearl Pathways Case study Medical Writing Biopharma

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Company  Overview  

Pearl Pathways is obsessed with accelerating life science product development for our clients. We are an extension of our clients’ teams. We partner with the clinical team, in-house regulatory experts, the quality compliance specialists, the quality auditors, and the senior leadership team to get lifesaving diagnostics and therapeutics on the market sooner. Our talented staff is focused on getting critical research done, ensuring high quality and efficient manufacturing of products, accelerating global product registrations, and keeping our clients up to date on current regulatory and quality compliance best practices for life science product development.

Pearl IRB: Protecting human subjects and driving improved value and efficiency in protocol reviews and study implementation

Pearl ReGXP: Providing regulatory & quality consulting, and auditing services

Pearl IDEAS: Offering strategic product development assistance through our life science consulting practice

 

 

 

 

 

 

 

29 E McCarty Street, Suite 100 Indianapolis, IN

317.899.9341 ph

317.602.6554 fax

www.pearlpathways.com

www.pearlirb.com  

Situation: A startup biopharmaceutical company asked Pearl for assistance with medical writing to prepare for needed publications in support of an upcoming IND approval and launch. The client required assistance composing several pharmacokinetics publications, abstracts and posters.

Solution: Pearl provided a team of medical writers to help the company for 4 months producing a total of 8 publications and 8 abstracts/posters. Pearl led all medical writing activities and worked across a cross functional team at the client to project manage the project including efforts to secure needed references and raw data. Pearl also worked to ensure all publications met journal publishing requirements.

Result: Pearl worked closely with the client team, and provided high quality draft publications, abstracts and posters. As a result of Pearl’s work, the client exceeded project deadlines, and was extremely pleased with the quality of the writing, and is currently seeking further work with Pearl.

 

Medical  Writing  Client:  Biopharma  Startup  Client