Services

Training

In addition to the qualification and basic training, continuous training is recognized to maintain, upgrade and update skills. Continuous training is essential to maintain the optimum performance of any system and associated personnel, which is very crucial for organizational development and success. Ethitrials can provide bespoke, tailored training sessions to meet client's specific needs in the areas of:

  • Good Clinical Practice / Advanced GCP
  • Good Laboratory Practice/ Advanced GLP
  • Good Clinical Laboratory Practice
  • Good documentation practice
  • Recent advances in Indian regulatory environment
  • SOP development and training

Auditing And Monitoring

Independent auditing and monitoring have become a routine element of quality management. It provides an insight into the quality of your clinical research at a point in time. In case of pharmaceutical and drug development industry, it has become a regulatory expectation. These audits are usually undertaken by an independent team of specialist auditors within a sponsor company, or they can be outsourced by the sponsor to a third party service provider. The conduct of GCP quality audits is becoming an increasingly challenging process owing to the complexity of clinical trials and the location of investigator sites. Ethitrials has a team of auditors having their expertise in following services:

  • Independent study audit/monitoring
  • Medical monitoring
  • Co-monitoring
  • Pre-regulatory audit consultation and auditing
  • Independent QA monitoring
  • Post-trial documentation review
  • Third party vendor assessment

Medico Marketing

  • Medical support documents

    • CME modules, Slide kit preparation, Product monograph, Scientific compendium, Leave behind literature, Visual aids, Therapeutic rationale, Medical insight literature, Training manuals, Package inserts, Newsletters, FAQs, Literature for patient education, Manuscript preparation and publications, other promotional materials

  • Training sessions for Marketing Personnel
  • CME and Symposium conductions
  • Post marketing clinical research and data collection studies
  • Medical content and website development

Clinical Trial Management

Medical Writing

  • Study designing and conceptualization
  • Regulatory dossier preparation (Protocol, PIS-ICF, CRF, IB, Patient diaries, study rationale etc.)
  • Regulatory dossier presentation (NDAC, SEC etc.)
  • Safety narratives
  • Preparation and updation of CTD
  • Medical review of clinical study report

Operations

  • Site feasibility and selection
  • Site management activities
  • Project management
  • Data management and biostatistics

IP management

Medical Translation

Medical translation is the translation of technical process/ flow chart, regulatory, clinical or marketing documentation, software or training curriculum for the pharmaceutical, medical device or healthcare fields. Aside from linguistic skills, it requires specific training and subject matter knowledge in order to translate medical content. It requires precision and up-to-date technical knowledge by every member of the translation team.

We provide full-service translation for pharmaceuticals companies, contract research organizations, manufacturers of medical and surgical devices and healthcare institutes and are known to provide clear, accurate translation of your high-value information.

We provide translation services for following (but not limited to):

  • Informed Consent Forms
  • Case Report Forms (CRF)
  • Clinical Protocols
  • Adverse Event and Serious Adverse Event documentation
  • CRA Training Materials & Videos
  • Patient Reported Outcomes (PRO)
  • Patient Information
  • Quality of Life (QoL) measures
  • SOP Procedures
  • Patient Recruitment Materials
  • Manufacturing Process Descriptions
  • Regulatory Documents/ Dossiers
  • Production Manuals
  • Product Labels
  • Package Inserts and Labels
  • Data Sheets
  • Instructions for Use (IFU)
  • IVR
  • Marketing Collateral
  • Scientific Journal Articles
  • Corporate Websites and Portals

Archival

Whether it is for compliance reasons or to better utilize the space in your office, Ethitrials can access, evaluate, move, store, archive and index your information in ways that makes practical and economic sense.

We provide full-service translation for pharmaceuticals companies, contract research organizations, manufacturers of medical and surgical devices and healthcare institutes and are known to provide clear, accurate translation of your high-value information.

We offer a full line of document and IP storage services, from legacy storage to active file management, to help you minimize storage costs, optimize access and maximize the value of your important documents, records and files with utmost compliance to regulatory requirement.

  • Document archival
  • IP retention

Health Policy Research

Health policy researchers, conduct research, generate reports, and administer health care policies and programs. Working for government authorities, consulting firms, universities, research institutes, hospitals, non-governmental organizations, and international organizations.

Some of the key services provided are:

  • Aid and expand government or private health policy by reviewing literature, analyzing data, health program promotions, regulation and financing and suggesting higher authority on such cases.
  • Conducting health projects or programs by designing for various organization
  • Maintain, update and manage health related information
  • Information compiling from various private and public organization for analyses and then prepare the reports and submit to designated organization
  • Monitoring, auditing and evaluation of health care programs managed by health agencies or private organization
  • Evaluating any discrepancies in the health documents or database and aid the respective personnel for its resolution
  • Preparation of documents such as articles, newsletter or magazines to aid the general public or private organization by providing the facts
  • Expression of views of an association to government authorities, common people through digital platform