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Medical Writing

Clintrac’s skilled medical writers can produce high quality compliant medical and scientific communications in an efficient and timely manner. Our team is capable of producing high quality data of phase I - IV that strictly adhere to ICH-GCP guidelines. Our protocol development team consults with key opinion leaders in specific therapeutic area that helps to maintain the study assessment to ensure that new clinical developments in specific field are addressed.

From protocol writing to the preparation of clinical study report, our medical writers team collaborates with the biostatisticians to produce comprehensive data in all stages of clinical development. Our experienced medical writing professionals are committed to work in accordance with US/EU/ICH guidelines and regulations to deliver a wide range of high-quality clinical materials on time.

We have internal quality control reviews at each step to ensure accuracy and consistency. Additionally, senior management plays an active role throughout the review process. Every document goes through a rigorous internal quality process to ensure the compliance of ICH-GCP and applicable regulatory guidelines.

Our Medical Writing services include:

 

Investigator brochure.

Protocol preparation from Phase I-IV.

Informed Consent Form.

Case Report Form.

Clinical Study Report.

Patient Safety Narratives.

Standard Operations Procedures.

Pre-marketing and Post-approval Annual Reports.

Risk Management Plans.

Scientific Literature Research.

 

 

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