Dr. Dipti Tendulkar Email & Phone Number

Pune, Maharashtra, India

Remote Patient Monitoring Solutions (RPM): Currently working on developing an app which provides disease case management oversight of chronic conditions such as CHF, COPD, Type 2 Diabetes, Hypertension, and Asthma. Electronic Medical Records (EMR): Responsible for implementation of EMR/HER interfaces at client sites. Support, Documentation, Training, Testing, and Maintenance of EMR system along with the IT team. Scientific Writing (SW): Developing high-quality scientific content by means of all necessary research, scientific writing, editing, and fact checking, to meet deadlines and work within project scope and objectives. Medical Communication (MedComm): Project roadmaps and functional documents. Writing and editing documents like abstracts, manuscripts, training documents (PPTs), user manuals, promotional handouts and many more for publications.

Medical Information Services/Systems (MIS): Global project for the medical information services. A web based application to answer product specific inquiries from the physicians across the globe and to create and provide global responses to be sent to the healthcare professionals. Stakeholder communication: Regular communication with the client and LOCs on a global scale and other client and project co-ordination responsibilities such as invoicing, trackers, and dashboards. Preparing PowerPoint presentations for training and CME. Building project roadmaps, functional documents, and SOPs as per the global standards. Updating product labels and monographs for African and Sub Saharan countries. Quality control. Interact with and advise consultants/clients in US as a subject matter expert to formalize data sources, understand data, acquire and use relevant business knowledgeScientific Information Management (SIM) Project: Writing clinical documents including, but not limited to: clinical protocols, clinical and clinical pharmacology study reports, NDA/IND submission summaries, briefing documents and responses to regulatory authority questions, clinical sections of the IMPD for clinical trial applications, and investigator brochures. Development and review of Clinical Study Reports, Investigator's Brochures, Safety Reports, Efficacy Reports, and commercial documents. Successfully compiled integrated report according to CTD Format for Canadian submission. Working on CTD and e-CTD for US-FDA Submission. DSURs, PBRERs, RMPs, ISSs and ISEs in multiple therapeutic areas. e-CTD submissions for regulatory documents to the FDA. Collating and submitting regulatory documents such as investigational new drug application annual reports (IND ARs), new drug application periodic reports (NDA PRs) and investigator’s brochures (IBs). Assisting in internal audits. Implementing ICH-GCP guidelines.

Pune, Maharashtra, India

ePRO- electronic patient reported outcomes, widely used in clinical trials these days. •Medical write-ups for various therapeutic conditions.•Preparing e- health diaries applications for better subject compliance and more accurate field with Basic Quality checked data collection for clinical development programs.•Performance management system development, implementation & Supporting for designing the enterprise and functional architecture, ensuring timelines.•Data Analysis , Designing screens & Deciding treatment plans for Specific project as per Company SOP’s

EIS or electro interstitial scanning is a whole body scanning system which is safe, effective and non invasive preventive screening of a healthy person to get a guideline about his/her present health status and future risk analysis•Medical educational writing for patients & physicians. •Developed Systems and Processes (SOP) for various services.•Data search and collection to gain thorough knowledge about the worldwide usability along with pros and cons of this product

Research Associate on a chronic disease management project. Key Area of work: Hypertension, Diabetes, Oncology and Obesity• Assist in managing clinical trial project related services or function as Research associate for small scale projects, ensuring on-time, on-budget performance• Scientific writing/ Medical Writing with Clinical Documentation.• Worked on ePRO or electronic patient reported outcomes and eHealth Diaries • Data search through various media like reference books, web search, journals and literature• Monitor investigator sites for GCP compliance according to Bilcare’s SOPs and/or client guidelines• Content development for the project related topics such as hypertension, diabetes, oncology and obesity• Work with GBS Line Functions and QA to identify potential quality issues and implement actions to resolve them. Work with GBS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality to the next level if no solution can be achieved

•Critical case management including BLS and ACLS•Clinical supervision and training of the Emergency Department Junior Medical Staff and Emergency Nurse Practitioners working in the Emergency Department as well as the organisation and delegation of clinical work

•Patient admissions ,Ward rounds, Casualty management•Document history & physical examination, Formulate differential diagnosis

I started working in Sanjeevan hospital as an observer in 2004 and completed my internship from the same in 2006.

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