Pharma Instinct has a team of experienced medical writers to provide high quality clinical study documents (including CTDs) compliant with ICH guidelines and regulatory requirements. From protocol writing to the final study report preparation, our medical writers collaborate with biostatisticians and project team members to produce comprehensive, submission-ready documents for all stages of clinical development. Every document goes through a rigorous internal quality assurance process ensuring high quality deliverables, on-time. We provide medical writing services as part of the comprehensive clinical trial program or as a stand-alone service. Our medical writers help you in the preparation of the following:
- Investigator brochure
- Clinical study protocols
- Informed consent forms
- Case record form
- Log books
- Study assessment questionnaires
- Patient dairies
- Clinical study reports – Phase I to IV
- Abstracts and manuscript
Our team of experienced statisticians help our clients in developing best research designs and models. Our team strive for accurate results and data analysis. They also make sure that our clients, those who know statistics and those who do not know statistical analysis, understands importance of techniques used and how the results can be correctly interpreted. Our team is fully skilled to use any statistical software.
We do Clinical Trial Data Analysis, Thesis Work Data Analysis, Research Design & Hypothesis establishment.
Analyzed data is presented in High Quality professionally Designed Graphs & Tables.
Each analysis undergoes quality assurance check before its release to the client.