Contract Research Organization Bangalore, Contract Research Organization India

COVID-19

SYNCORP COVID-19 SERVICES (Provide support to fight against the global crises)

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. Most people who fall sick with COVID-19 will experience mild to moderate symptoms and recover without special treatment.

Syncorp partner with global Sponsors to develop and test therapeutic drug for approval and market readiness.

Managing Employees, Patient safety and Trial progress:

HOW COVID-19 SPREADS:

The virus that causes COVID-19 is mainly transmitted through droplets generated when an infected person coughs, sneezes, or exhales. These droplets are too heavy to hang in the air, and quickly fall on floors or surfaces.

You can be infected by breathing in the virus if you are within close proximity of someone who has COVID-19, or by touching a contaminated surface and then your eyes, nose or mouth.

HOW TO PREVENT COVID-19:

Protect yourself and others around you by knowing the facts and taking appropriate precautions and Follow advice provided by your local health authority.

HOW TO PREVENT COVID-19:

  • Clean your hands often. Use soap and water or an alcohol-based hand rub.
  • Maintain a safe distance from anyone who is coughing or sneezing.
  • Wear a mask when physical distancing is not possible.
  • Don’t touch your eyes, nose or mouth.
  • Cover your nose and mouth with your bent elbow or a tissue when you cough or sneeze.
  • Stay home if you feel unwell.
  • If you have a fever, cough and difficulty breathing, seek medical attention.
  • Calling in advance allows your healthcare provider to quickly direct you to the right health facility. This protects you and prevents the spread of viruses and other infections.

WEAR MASKS

Masks can help prevent the spread of the virus from the person wearing the mask to others. Masks alone do not protect against COVID-19 and should be combined with physical distancing and hand hygiene. Follow the advice provided by your local health authority.

SYNCORP SUPPORTING STUDY SPONSORS:

Syncorp Health Clinical Expert team (Subject Matter Experts) constantly evaluating the changing conditions of the pandemic situations to ensure the health and safety of patients and employees. Team monitor the government regulations to ensure our operational business is aligned with government regulations and guidelines and advise sponsors how to proceed with their on-going and planned trials.

We understand planning is an important part of our weekly Executive Committee meeting at Syncorp Health, and we meet regularly to focus on relevant issues (but not limited these) to ensure we support the global sponsor to manage the clinical trials.


  • Assess the Trial Staff ability to work remotely.
  • Provide guidance on our work environment risks.
  • Assess the Trial monitoring plans.
  • Review the site impact on study and create contingency plans.
  • Review regulatory, ethics committees and other authorities’ impact on studies.

PROJECT CONTINUITY:

  • Continuously monitor and maintain register of any issues with site availability and Project managers have contingency plans in the event of site closures.
  • Syncorp team experience in Asia PAC and staff maintain a register so that we can understand impacts in relation to regulatory authorities, ethics committees, importation authorities etc.
  • Syncorp constantly updates the study specific remote monitoring plans and SOPs as required to have specific approach to manage the studies.
  • Constantly we devise the project management solution required to manage the studies and work collaborative with trial sponsor, site, technology service providers and ECs.
  • At the event of national lock down, Syncorp assess the essential services must go on and work with sites and provide guidance as needed.

PATIENT ENGAGEMENT:

During pandemic situation patient travel to Research sites and social distancing is of a great concern and the restrictions may apply during the trial evaluation visit period, thus Syncorp Health adopts the necessary risks management plans and design to ensure continuity and compliance.

Syncorp provides the telemedicine or home-based visits to keep patients engaged in on-going studies and helps patients make up for missed visits at a later stage, when feasible. Wherever possible, Syncorp moves the trials to a remote or hybrid model to protect patients and to best meet their needs for in-home visits.


REGULATORY SUPPORT:

Syncorp Health subject matter expert (SME) and regulatory team provides the guidance on strategic, and operations and we support changing clinical trial operations during the pandemic, thus may Clinical trials need amendments, protocols, and study procedures modifications and advise you how to proceed based on a risk assessment for your individual challenge and provide support for EC and IRB submissions.

INDIAN COVID-19 Important Updates:

Useful link for further guidance

Top