Early Phase

With 14 years of operational experience, Cliantha offers wide array of early phase services accomplished by our trained professionals. These services can be accessed as part of an integrated program or as a stand-alone service at our clinical or multicentric site


Experience

5866
BA/BE
200
Early Phase
31
FIH
27
SAD/MAD
24
Drug-Drug interaction
23
PK/PD
15
Food Effect

Expertise

In various types of studies

Single and multiple dose

Parallel, Cross over, Partial Replicate and Full Replicate

Fasting, Fed & Sprinkle Applesauce

Long housing (confinement up to continuous 17 days)

Studies - Demanding frequent blood sampling - With long washout up to 45 days - Requiring continuous cardiac monitoring

Special Population

Multiple dose studies with 5 - 7 consecutive daily dosing

Hospital set-up BE studies

Proof of Concept studies

Various Routes of Administration (dosage forms)

  • Injection (IM, IV, Subcutaneous)
  • Oral (Tablets: IR,ER,SR,MR,CR,DR,ODT
    • Capsules: ER,MR,DR, Soft Gelatin)
    • Suspension
    • Granules
    • Sublingual
  • Rectal (Suppository & Foam)
  • Transdermal (Patch, Topical Cream, Topical Gel)
  • Vaginal (Tablet, Cream, Gel)
  • Pulmonary (MDI & Nasal Spray)

BA/BE-Phase 1 Achievements

  • 100+ derma/patch BE Studies (Adhesion/PK)
  • Successfully conducted the Open First to File study studies across geographical locations
  • 70+ studies with continuous Cardiac monitoring studies (Ranolazine, Propafenone, Flecainide etc)
  • 22 long housing studies (Potassium Chloride/Citrate)
  • 52 studies (37 pivotal, 15 pilot) for long washout (Levothyroxine, Enzalutamide, Aripiprazole, Empagliflozin and Linagliptin, Brexpiprazole etc)
  • 75 studies (53 pivotal, 22 pilot) for Hormonal preparations(Ethinyl Estradiol+Levonorgestrol, Desogestrel+ Ethinyl Estradiol, Levothyroxine, Methylprednisolone, Prednisolone, Hydrocortisone, Liothyronine etc)
  • 34 studies in Elderly population ( Brexpiprazole and Aripiprazole)
  • Phase I, Multiple dose, Placebo controlled study to evaluate the safety and tolerability of topical cream having long housing of 15 days
  • 06 Sublingual tablets studies (Nitroglycerin 0.6 mg) demanding frequent blood sampling
  • 08 studies for Biosimilars (Darbepoetin, Enoxaparin, Pegfilgrastim, Repoitin, Adalimumab, Trastuzumab)
  • Studies with stringent screening criteria, long housing, long washout, high sample size etc (Pegfilgrastim)

Integrated Departments

Medical Writing

Cliantha’s team of very experienced and highly trained medical writers are responsible for preparing the study protocols in line with the sponsor’s requirements and applicable regulatory guidance. The medical writing team also coordinates with the ethics committee for the necessary approvals

  • Protocol development
  • Protocol amendments
  • Informed Consent Forms
  • Case Report Form preparation
  • Clinical study reports
  • Bioanalytical sample analysis reports
  • Method validation report
  • Biostatistical reports

Our medical writing services are in full compliance with applicable regulatory requirements.

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Clinic

India

Location: Ahmedbad, Vadodara, Noida

  • 12 clinical units, 513 beds, 14 ICU beds & 25 doctors
North America

Location: St. Petersburg, FL, Neptune, NJ & Mississauga

  • 6 clinical units, 247 beds, 19 ICU beds
  • Complete On-Site Pharmacy

Lab Services

Cliantha research provides scientific expertise with state-of –the-art technologies reinforced by commitment for quality delivery. Our comprehensive lab services include bioanalytical, central lab testing, PK services, immunogenicity testing etc.

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Biometrics

Biometrics is one the centre's of excellence that Cliantha research excels into. With more than 14 years of experience, we have been successful in carving the niche for ourselves. With more than 100 trained professionals, biometric team provides efficient and cost effective outsourcing solutions for Clinical Data Management, Biostatistics & Programming and CDISC.

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Regulatory

Cliantha Research has been successfully inspected or audited by various regulatory agencies across the globe. Our impeccable regulatory track record is the result of strict adherence to the applicable standard(s) and guidelines laid by ICH, FDA, EMA, Clinical and Bio-Analytical bodies. Our enshrined values : Science & Integrity are the foundation for our planning and execution assisted with robust knowledge of the regulations.

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