Save valuable time and money, while increasing efficiency and productivity, by avoiding repetitive and labor-intensive manual work as well as frustrating formatting errors, with high-quality templates for clinical evaluation plans (CEPs) and reports (CERs) for EU MDR 2017/745 submissions, and clinical study protocols (CSPs) and reports (CSRs) that support 510k Food and Drug Administration (FDA) submissions.
Clinical Document Templates that…
- Follow the EU MDR 2017/745-recommended MDCG 2020-6 guidelines
- Follow the FDA-recommended ICH E3 and E6 guidelines
- Contain extensive instructions and practical example text
are easy to use, review and edit
- Have an appealing layout that is robust and resilient to formatting errors
The clinical evaluation and clinical study templates were developed by Clinical Study Templates for Microsoft® Word with both the author and reviewer(s) in mind.
The integration of automated formatting features through the customized Styles gallery, and the exceptional ease of using these clinical study templates allow experienced authors to quickly draft clinical documents from beginning to end, and offer novice writers clear guidance (including explanations and example text) to create clinical-grade, high-quality documents that ensure consistency across CERs, CEPs, CSRs and CSPs.
Moreover, their robust design makes these templates resilient to notorious formatting issues (e.g., text and figures jumping all over the place, black boxes that cover heading numbers, misalignment of text, mismatching font types, etc.).
Hit the ground running, and take off with a flying start.
Company Details
- Employees
- 1
- Founded
- -
- Address
- 33024 Soquel St, Union City,california 94587,united States
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Keywords
- Clinical Study Report, Clinical Study Protocol, CSR, CSP, FDA, Template, Microsoft, Word, Medical, Scientific, Technical, Writing, Consultation, CER, CEP, Evaluation, Device, PMCF, Clinical Evaluation Report, Clinical Evaluation Plan, SSCP, Literature Review, MDR.
- HQ
- Union City, California
Clinical Study Templates Questions
Clinical Study Templates's website is https://clinicalstudytemplates.com
Clinical Study Templates's LinkedIn profile is https://www.linkedin.com/company/clinicalstudytemplates
Clinical Study Templates has
1 employees.
View email and phone details for 1
employees at Clinical Study Templates.
Clinical Study Templates's industry is
Pharmaceutical Manufacturing
Clinical Study Templates's top competitors are
Clinical Scientist Group,
C-Trials Global Inc.,
Fidelity Health Services,
Kinapse,
Morula Health,
Narrativa Ai,
Veridix, Part Of Emmes Group,
Emmes Group,
Medidee - Now A Part Of Veranex,
Study Builders.
Clinical Study Templates's categories are Pharmaceutical Manufacturing
Clinical Study Templates's founding year is 2018
