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  CONTACT US TODAY: (888) 504-1115 (press Option 1)   |   Silver Lake Executive Campus; 41External link opens in new tab or window University Drive, Suite 450, Newtown, PA 18940, US

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EXCELLENT SERVICES


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We will work hard to show you what a beautifully written and properly structured regulatory research or technical document can look like.   We have the education and clinical expertise needed to advance medical and scientific documents from inception to approval. Old-fashioned values and integrity are always in style.  We are highly motivated, well-organized, resourceful, functionally independent, detail-oriented, reliable, and flexible.  Confidentiality is highly respected.  We are polite and diplomatic team communicators. 


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Quality Systems

A Risk Management Approach 


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We help clients meet document quality objectives by first promoting the adoption of efficacious, efficient and adaptive processes that inevitably bake improved team skill sets into the process going forward, especially when guided by our timely and relevant quality benchmarking metrics aimed at minimizing systematic error.  Meeting corporate,  regulatory, and academic demand for high-quality scientific research documents marked by accurate, current, and unambiguous report claims is absolutely crucial and doing so leads to the objective of confident fulfillment of quality standards that are industry hallmarks.  The coveted by-product is an overall reduction of risk, a cross-functional proactive achievement and a wise, forward-thinking business investment.   

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PROJECTS OF ANY TYPE


Clients sing our praises, music to our ears!


Our Medical Writing, Pharmacovigilance and Document Quality Review teams can work in concert with yours in the production of high quality research and technical documents, which is a great way to facilitate a successful submission or publication plan.  That sounds good! 


What do our reports sound like? 


We harmonize biomedical expertise and statistical literacy with thoughtful and comprehensive data interpretation as well as with insightful observation of patterns and trends.  Thorough and pervasively accurate accounting and keen awareness of minute but noteworthy details are achieved.  Plausible, evidence-based arguments are advanced and comprehensive treatment of study objectives and endpoint-driven conclusions are championed. 



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Our scientists, licensed healthcare professionals, and educators have been harnessing the power of the pen since 2006! 

We create accurate, comprehensive, clear, concise, timely and compliant reports that are well-grounded in reliable data and analyses transposed upon the Client's corporate strategy. 

Client confidentiality is highly respected.

We are Licensed & Insured.

Request a brochure today!

Our Library of Documents & Services:

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Academic, Business & Paralegal Documents & Services

  • Small Business:  Business Plans, Bids & Proposals, web & marketing  copy, promotional materials

  • Science & Clinical Education:  didactic program development, test question preparation,  clinical scenarios

  • Legal Nurse Consulting

  • Pricing:  hourly or project-based

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Editing Services

  • Copy/Line

  • Stylistic

  • Substantive

  • Scientific

  • Liberal arts & professional arenas 

  • Pricing:  by page or project-based


Clinical Trial Disclosure & Transparency Services

  • Clinical trial data sharing & publication as required by corporate policy and global regulatory authorities.  

  • Pricing:  hourly or project-based


Quality Management Services

  • Document Quality Review (DQR)

  • Quality Control (QC)
  • Quality Assurance (QA)
  • Quality Benchmarking

  • Standard Operating Procedures (SOPs) & eLearning
  • Learning Management Systems
  • Risk Management

  • Pricing:  hourly or project-based

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Medical Writing

Regulatory, Publications & Pharmacovigilance Documents

  • Clinical Study Reports (CSRs)

  • Patient/Case Narratives

  • Clinical Study Protocols, ICFs

  • Investigator Brochures (IBs)

  • Clinical Overviews (COs)

  • Briefing Documents

  • Labeling Documents

  • Agency Response Documents
  • Submission-Related Summary Documents including Modules 2 & 5 (eCTD format)
  • Integrated Summaries of Safety & Efficacy (ISS, ISE)
  • Summaries of Biopharmaceutic Studies and Analytical Methods
  • Periodic Safety Update Reports (PSURs)
  • Case Review & Assessments
  • Publications

  • Pricing:  hourly or project-based

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Services | Testimonials | Contact Us


Address: External link opens in new tab or windowSciMed Writing LLC - Science Works Division, Silver Lake Executive Campus; 41 University Drive, Suite 450, Newtown, PA 18940

Phone: (888) 504-1115 (press Option 1) | Email: scienceworksdivision@scimedwritingllc.net | Office Hours: Monday-Friday 9:00 AM to 5:00 PM


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