Our expert writers develop Investigator's Brochures (IBs) that provide a comprehensive summary of the clinical trial, detailing the investigational product, trial design, and safety data to help investigators understand the scope of the study.
Nilasari drafts Informed Consent Forms (ICFs) that are easy to understand, ensuring that patients are fully informed about the clinical trial, risks, and benefits, in compliance with regulatory requirements.
We prepare patient information sheets that clearly communicate important trial details to participants, helping them make informed decisions about their involvement.
Nilasari provides well-designed Case Record Forms (CRFs) to ensure the accurate and efficient collection of patient data during clinical trials.
Our site training manuals are tailored to help clinical sites understand their roles and responsibilities during the trial, with detailed instructions to ensure compliance and proper data handling.
We develop medical monitoring manuals that provide guidance on managing patient safety, monitoring adverse events, and ensuring the integrity of the study throughout its lifecycle.
Nilasari prepares comprehensive summary documents for regulatory bodies to support your submissions, ensuring they meet the required guidelines for approval.
Our team prepares Clinical Study Reports (CSRs) that summarize the entire clinical trial process, including results, analysis, and conclusions, in accordance with regulatory standards.
In addition to technical writing, Nilasari offers a full spectrum of medical engagement and medico marketing services designed to enhance communication with both healthcare providers and patients. We ensure that all materials align with your brand, meet regulatory requirements, and effectively communicate key messages.