we make clinical trials

affordable...

reliable

even in difficult times...

About Us

MedianaStatistics, a privately owned contract research organization, has been established in 2015 in Ukraine. The company staff represents well-trained medical doctors with over the 20-year history working with Randomized Clinical Trials (RCT) with drugs in compliance with Good Clinical Practices. With professional connection to local medical universities and hospitals, the staff acted as investigators to Pfizer, F. Hoffmann-La Roche, Wyeth and as Contract Research Organization to dietary supplement industry such as UASLabs (USA), Biocare Copenhagen (Denmark), Vesale Pharma (Belgium), NaturaMedicatrix (Luxemburg), Nordic Biotics (Poland). In our portfolio, you will find some publications in the recognized US and EU peer-reviewed medical journals.

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Sergiy Gerasymov, MD, PhD

Founder and CEO
CRO MedianaStatistics
Lviv, Ukraine.

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Victor Bobyk, MD

Advisor, Neonatology
Lviv City Children Hospital
Lviv, Ukraine.

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Nataliya Dementieva, MD

Advisor, Pediatric Surgery-Oncology
NPE
Dnipro, Ukraine.

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Prof. Nataliya Henyk, MD, PhD

Advisor, Obstetrics-Gynecology
Ivano-Frankivsk National Medical University
Ivano-Frankivsk, Ukraine.

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Assoc. Prof. Victor Malyuk, MD, PhD

Advisor, Obstetrics-Gynecology
Odessa National Medical University
Odesa, Ukraine.

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Vitaliy Fedevych, MD, PhD

Advisor, Urology-Andrology
Lviv State Clinical Hospital
Lviv, Ukraine.

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Prof. Iryna Paliy, MD, PhD

Advisor, Family Medicine
Vinnytsya National medical University
Vinnytsya, Ukraine.

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Prof. Larysa Sydorchuk, MD, PhD

Advisor, Family Medicine
Bukovyna State Medical University
Chernivtsi, Ukraine.

Memorandum

As the world becomes more regulated clinical trials with dietary supplements become popular worldwide. As opposite to drugs, dietary supplement are not requested by the healthcare or food regulatory offices, such as EFSA or FDA, to undergo clinical trial, while from the other hand the health or function claims are prohibited by these authorities without good clinical background. The truth of the day is that many manufacturers of dietary supplements would prefer to have their products tested in clinical trials backing up their market claims, but budgets of these trials are financially devastating... We come to fill in this gaps by offering economy clinical trials for food and dietary supplement that further can be used for health, function claims or for a new drug applications…

What Do We Offer?

As of May 01, 2024, MedianaStatistics offers economy clinical trials on:
  1. Prevention of Mastitis in Breastfeeding Women;
  2. Birth Outcomes and Infant Health;
  3. Management of Irritable Bowel Syndrome;
  4. Prevention of Common Colds in Adults and Children;
  5. Dietary Supplements in COVID-19 Outpatients;
  6. Dietary Support in Sarcopenia;
  7. Dietary Supplementation in Glucose Intolerance;
  8. Dietary Supplements in Osteoarthrosis and Lumbar Pain;
  9. Dietary Supplements in Anxiety;
  10. Dietary Supplements in Bacterial Vaginosis;
  11. Dietary Supplements in Male Infertility.
  12. Your Clinical Trial on Request.

Our Services

The Approach

We run clinical trials with dietary supplements as if they are drugs, meaning that all applicable strict rules for a new drug investigation, including patient insurance, data monitoring and verification etc., are applied for your dietary supplement.

As a result, you have a clinical evidence of the highest possible standard ready for correspondent applications both to EFSA and FDA, with a difference that we offer economy of the expensive challange. Order a pricelist for your RCT.

BEFORE THE CLINICAL PHASE OF THE STUDY

  1. Study Protocol and its revisions;
  2. Informed Consent Form and its revisions;
  3. Patient Information Leaflet and revisions;
  4. Study announcement poster and revisions;
  5. Case Report Form, clean version;
  6. Case Report Form, annotated version;
  7. Database file;
  8. Investigational Product accountability Log;
  9. Investigational Product storage temperature Log;
  10. Sample of label(s) attached to investigational product containers(s);
  11. Instructions for handling of the Investigational Product and trial related materials;
  12. Protocol specific annotated Medical Record Form;
  13. Subject Screening Log;
  14. Master Randomization List;
  15. Subject Identification Code List;
  16. Subject enrolment List;
  17. Investigator signature List Form;
  18. Investigator brochure and updates;
  19. Study Feasibility Form;
  20. Decoding procedures Form;
  21. Pre-trial monitoring Form;
  22. Registration of the Study at public international registry;
  23. Construction of the Master File;
  24. Consultation/Coordination of the Investigational Product certification;
  25. Screening for clinical sites, investigators:
    1. Certification, accreditation, external quality assessments;
    2. Identification of the potential investigators;
    3. Collection of information on laboratory facilities, certification, methods, normal ranges for laboratory tests included in the Protocol;
    4. Commenting on the Protocol procedures;
    5. Instructing and training on the Study procedures, operations, including record keeping, recording in the Case Report form, the investigational product handling;
    6. Supply of the Investigator Site File;

DURING THE CLINICAL CONDUCT OF THE TRIAL

  1. Consultations as to Good Clinical Practices in application to the Study;
  2. Ongoing consultations of Investigators through the study;
  3. Randomization of subjects;
  4. Coordination of the investigational product supply to the study sites;
  5. Coordination of study centers;
  6. Monitoring for accountability and storage of the investigational product at the study sites;
  7. Monitoring of the subject enrollment;
  8. Consultation on keeping the documents in the Investigator Site File;
  9. Review of the signed Informed Consent Forms;
  10. Review of the source documentation, resolution of the discrepancies, during the Study;
  11. Review of signed, dated and completed Case Report Forms;
  12. Transfer of the data from the Case Report Forms to electronic database;
  13. Assistance in constructing notification by investigator to Your Company of adverse effects;
  14. Interim or annual reports to the Ethical Committee;
  15. Database management;
  16. Registration of the database in the authority;
  17. Communication to Ethical Commission(s).

AFTER COMPLETION OF THE TRIAL

  1. Preparing the final close-out monitoring report;
  2. Consultation of the Investigator as to preparation of the final report to the Ethical Committee;
  3. Assistance in Archiving of the Study Documentation;
  4. Publication of the database on the public Web sites;
  5. Decoding of subjects that received active or control intervention;
  6. Perform Statistical Analysis;
  7. Preparing Final Study Report;
  8. Writing the Article in English

Our works and publications

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"Probiotic supplement reduces atopic dermatitis in preschool children: a randomized, double-blind, placebo-controlled, clinical trial"

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"Role of short-term use of L. acidophilus DDS-1 and B. lactis UABLA-12 in acute respiratory infections in children: a randomized controlled trial"

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"Role of Lactobacillus rhamnosus (FloraActive™) 19070-2 and Lactobacillus reuteri (FloraActive™) 12246 in Infant Colic: A Randomized Dietary Study"

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"Oral Intake of Lactobacilli Can Be Helpful in Symptomatic Bacterial Vaginosis: A Randomized Clinical Study"

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"Dietary supplementation with a novel l‐carnitine multi‐micronutrient in idiopathic male subfertility involving oligo‐, astheno‐, teratozoospermia: A randomized clinical study"

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"The role of nutritional support with probiotics in outpatients with symptomatic acute respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled dietary study" The study has been conducted in force majeure circumstances

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Links
Customized Software Design

At client's discretion, our software engineers develop online protocol-specific electronic data capture systems and applications assisting real time patient tracking and data analysis.

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Statistics

The easiest way is to enroll a million patients taking a study drug and a million patients taking placebo. But this is an unjustified luxury that does not make a drug more efficient…

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Contacts:

+380679375951

MedianaStatistics CRO, 15-A Horynya 22, Lviv, 79012, Ukraine