It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

Reputed Client of China



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Meeting MI & PV Obligations for a COVID-19 Vaccine: Partnering for Multi-Country Compliance

22 Jun 2023


Lambda Therapeutic Research partnered with a leading COVID-19 vaccine manufacturer to establish their Medical Information (MI) and Pharmacovigilance (PV) obligations for a multi-country vaccine launch. Immediate challenges anticipated included and were not limited to the uncertainty of the anticipated volume and availability of skilled resources during the Pandemic. Discover how Lambda implemented effective solutions and completed the project successfully.

Complexities & Challenges:

  • There was a substantial increase in the volume of MI and PV obligations due to the launch of a COVID-19 vaccine pan India and globally.
  • Varied regulatory requirements across the globe and ensuring compliance seamlessly.
  • The monitoring of safety data reported from multiple sources added complexity to the PV obligations.
  • Hiring skilled resources in large numbers was a significant challenge, especially given the impact of the pandemic on the workforce.


  • Established a 24x7 call center for MI & AE reporting to educate and provide correct information to consumers and healthcare professionals (HCPs).
  • Recruited and planned necessary skilled resources to provide PV services.
  • Expedited training to onboard resources quickly for the project.
  • Ensured proper resource management by calculating the requirement of extended working hours for contingencies.
  • Regularly assessed each resource before and after onboarding based on quality and compliance parameters.
  • Successfully managed over 10,000 calls and Individual Case Safety Reports (ICSRs) in the database in less than a quarter.


  • The successful completion of the project became a significant milestone for the sponsor.
  • The project was executed with excellent Service Level Agreements (SLAs) and adherence to regulatory compliance, ensuring high-quality work.
  • Lambda's adherence to all necessary requirements and standards was reflected in the successful completion of subsequent inspections and audits.
  • As a result of the successful collaboration, Lambda is now the preferred partner for the sponsor's future PV obligations.

Lambda Therapeutic Research provides comprehensive drug safety & pharmacovigilance services, encompassing all clinical and post-marketing phases. Our well-established PV framework ensures thorough safety monitoring and regulatory compliance for both clinical and commercial products, offering end-to-end support across the entire life cycle of medicinal products.

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