Objective:
Our client approached us with a Clinical Evaluation Report (CER) assignment for a Class IIa medical device. We were required to prepare end-to-end document; however, the literature search strategy was prepared at the client end based on the search terms provided by us.
Objective
The client approached us to develop the PBRER for one of its marketed product (therapeutic area: diabetes). The regulatory agency will use the PBRER to assessproduct’s benefit/risk profile, and their analysis of the results can have a large impact on the product’s future.
Objective
To train and mentor the doctors on the good medical writing practices and address their publication related challenges.
Objective The client approached us with a challenging project that required the development of meta-analysis on the effect of phenobarbit one in patients with status epilepticus The use of phenobarbit one for the treatment of status epilepticus is not as popular as other therapies. Prior to the initiation of the project, the client specified that…
Objective The client approached us to develop the CSR for a phase 1 trial (therapeutic area: bone disorder). It was a challenging project that required to liaise with the different departments of the organizations to collect the generated data in the clinical study. Being in the different time zone also make the project quite challenging.…
Objective
The client (a leading pharmaceutical company) approached us with a project that required conducting a survey with the doctors. The survey was designated to study and evaluated the efficacy of a popular antifungal ointment in topical fungal infection.
Objective
The client specified that they required an intensive Medical Rationale Document (MRD) to be developed for a global study involving Indian subjects. The client required us to pool out data from the raw tables and global clinical study reports (CSRs) provided for the development of the MRD.
Objective
The client approached us with a manuscript writing project which required drafting the manuscript, getting the same approved from the client and investigators, suggest a target journal, and submit the manuscript to the selected journal.
Objective The client approached us with a challenging project that required the generation of consensus statement for prophylactic management of a major orthopaedic complication in Indian population. The project required tasks of identification of current prophylactic modalities used for prevention of the target complication in India, covering an advisory board meeting that discussed the future…
Objective
This assignment required us to train a group of nephrology consultants on various key aspects of medical writing. The training was planned to acquaint the trainees regarding the basics of medical writing in order to help them understand the different aspects of medical writing.
