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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Accelerating Patient Recruitment: Topical Tacrolimus for Atopic Dermatitis

07 Jul 2023

Successful Enrolment of 783 Patients across India, in Two Phase III Studies on Topical Tacrolimus for Atopic Dermatitis in Just 5 Months.


  • Atopic dermatitis (AD) is a prevalent chronic inflammatory skin condition characterized by itchy, eczematous lesions and small blisters.
  • Treatment goals for AD include managing dry skin, reducing inflammation, controlling itching, promoting healing, preventing infections, and minimizing flares. Long-term use of topical glucocorticoids is the primary treatment for AD but is associated with adverse drug effects (ADRs) such as irreversible skin atrophy.
  • Tacrolimus, an immunomodulator, is a safe and effective non-corticosteroid alternative for treating AD.
  • The study sponsor approached Lambda to support site enrolment for Phase III study for Tacrolimus Ointment in atopic dermatitis.

Study Details:

  • Lambda conducted two randomized, double-blind, vehicle-controlled, multi-center Phase-III studies to evaluate the efficacy and safety of topical tacrolimus in patients with moderate-to-severe atopic dermatitis.
    • Study-1: 0.1% Tacrolimus Topical Ointment
    • Study-2: 0.03% Tacrolimus Topical Ointment
  • The studies involved the application of tacrolimus topical ointment twice daily to a defined symptomatic area of 200 to 1000 cm2 of skin for a duration of three weeks.

Challenges Overcame:

  • Limited Awareness: Atopic dermatitis may be underdiagnosed or misdiagnosed, requiring increased awareness to educate patients and healthcare providers about the condition.
  • Stringent Eligibility Criteria: The recruitment process involved meticulous screening of participants who met specific criteria related to disease duration, affected area, and severity. These criteria included a minimum disease history of three months, a specified body surface area (BSA) for the affected area of atopic dermatitis, adherence to the severity range of moderate to severe according to the Hanifin and Rajka criteria, and a validated Investigator Global Assessment (vIGA) scoring system indicating at least moderate disease severity.
  • Patient Engagement: Maintaining patient engagement throughout the study duration was crucial to minimize dropouts and ensure adherence to the treatment protocol.

Our Approach:

  • Successfully tackled challenges related to stringent eligibility criteria, awareness, and patient engagement, employing effective strategies to ensure a diverse and representative study population.
  • Effective engagement with sites from the beginning of the studies to identify and recruit eligible patients.
  • Providing comprehensive training to sites on the necessary scales and scoring systems required for these studies.


  • 783 patients from across India were successfully recruited in just five months.

0.1% Tacrolimus Topical Ointment

429 Patients

19 Sites


0.03% Tacrolimus Topical Ointment

354 Patients

17 Sites

  • The achievement of recruiting a substantial number of patients within a short timeframe demonstrates Lambda's effective patient outreach and engagement strategies.

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