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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WHO Draft Guidance for Organizations Performing In Vivo Bioequivalence Studies

07 Mar 2019

The guidance covers major amendments; the points regarding the clinical study part are mentioned below:


  • The CRF should be sent to the IEC for review and approval together with the study protocol, if it is not part of the protocol.
  • Subject’s Entry and Exit to the facility should be recorded.
  • The volunteers/subjects should be given the opportunity to discuss their concerns with a physician regarding potential side effects or reactions from the use of the test product before participation in the trial. They should also be given the opportunity and sufficient time to discuss their concerns with their participation in the trial with individuals outside of the clinical research organization, such as friends and family members, if they wish.
  • Separate room (area) should be provided/designated for individual volunteers to obtain informed consent without compromising privacy.
  • There should be job descriptions for all personnel, including a description of their responsibilities. All job descriptions should be acknowledged and signed off by the staff member to whom it applies.
  • There should be a list of signatures of authorized personnel participating in each study.
  • Alarms should be located within arms-reach from the beds, to ensure that subjects who are unable to move to a medical emergency are able to alert CRO staff.
  • Facilities for changing and storing clothes and for washing and toilet purposes should be clean, well-ordered, easily accessible and appropriate for the number of users. Closed toilets should be alarmed and doors should be designed to ensure that they can be opened from the outside should there be a medical emergency.
  • Electronic data should be backed up at regular intervals. The reliability and completeness of these back-ups should be verified – data should not be selected but comprehensively backed up.

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