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.
|
|