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JSV Clinical Research Study Inc | Tampa, FL

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Top conditions

Hypertriglyceridemia (3 trials)

Migraine Disorders (3 trials)

Cardiovascular Diseases (2 trials)

Narcolepsy (2 trials)

Atherosclerosis (2 trials)

Top treatments

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Data sourced from clinicaltrials.gov

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Active trials

A study of olezarsen (isis 678354) administered subcutaneously to participants with severe hypertriglyceridemia (shtg).

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in particip...

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from ba...

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease (PREVAIL)

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD)...

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Ob...

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma (ATLAS)

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to...

Trial sponsors

Ionis Pharmaceuticals (3 trials)

Pfizer (3 trials)

Takeda (2 trials)

Apnimed (1 trial)

NewAmsterdam Pharma (1 trial)

Sanofi (1 trial)

Clinical trials

Research sites

JSV Clinical Research Study, Inc.

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A Study of TAK-994 in Adults With Narcolepsy

About this clinical trial.

Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study. The main aim of this study is to check if participants have side effects from TAK-994. Participants will take one of 3 different TAK-994 dose for 8 weeks. Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks. Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo. The study doctors will check for side effects from TAK-994 and placebo throughout the study. Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

At a glance

What medical conditions were being studied, what was the clinical trial testing.

Placebo, TAK-994

How many participants were enrolled?

Were placebos part of the clinical trial, when was the clinical trial conducted.

Apr 2021 - Nov 2021

How long was participation in the clinical trial?

Each participant will be in this study for up to 14 weeks. They will visit the clinic 10 times after the first dosing and there will be 2 overnight stays.

Key requirements

18-65 years

Healthy volunteers?

Entry criteria, view study results on registries, outcome measures, primary outcome measures.

Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period [Time Frame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)]

Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period [Time Frame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)]

Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period [Time Frame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)]

Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period [Time Frame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)]

Secondary outcome measures

Number of Participants With at Least One TEAE During the Double-blind Randomized Withdrawal Period [Time Frame: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)]

Number of Participants With at Least One Post-dose MAV in Laboratory Test During the Double-blind Randomized Withdrawal Period [Time Frame: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)]

Number of Participants With at Least One Post-dose MAV for Vital Signs During the Double-blind Randomized Withdrawal Period [Time Frame: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)]

Number of Participants With at Least One Post-dose MAV for ECG Parameters During the Double-blind Randomized Withdrawal Period [Time Frame: Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)]

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Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

You can join Smart Patients to discuss this trial with other members.

The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Inclusion Criteria

Exclusion criteria.

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A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

An open-label extension study of olezarsen (isis 678354) administered subcutaneously to patients with severe hypertriglyceridemia (shtg), study overview.

• Severe Hypertriglyceridemia

Intervention / Treatment

• Drug: Olezarsen

Detailed Description

Enrollment (estimated), expanded access, contacts and locations, study contact.

• Name : Ionis Pharmaceuticals, Inc.
• Phone Number : (844) 274-0709
• Email : [email protected]

Study Locations

• Royal Adelaide Hospital
• Royal Prince Alfred Hospital
• Dr Heart Pty Ltd
• Royal North Shore Hospital
• Medical Center Doctor Staykov EOOD
• Medical Center Diamedical 2013 OOD
• UHMAT Kaspela Ltd
• Medical Center Smolyan Clinical Research OOD
• Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD
• Medical Center Endomedical
• Clinical of Cardiology
• Diagnostic Consultative Center Equita (DCC Equita)
• Medical Centre "Nevromedics" EOOD
• Institut de Recherches Cliniques de Montreal
• Bluewater Clinical Research Group, Inc.
• Canadian Phase Onward Inc.
• Clinique des Maladies Lipidiques de Quebec Inc.
• MEDICUS SERVICES s.r.o.
• University Hospital Hradec Kralove
• EDUMED s.r.o.
• Fakultni nemocnice Ostrava
• Vseobecna Fakultni Nemocnice
• Endokrinologie Cerny Most s.r.o.
• MU Dr. Nina Zemkova s.r.o. Interni Ambulance
• Aalborg University Hospital
• Aarhus Universitet Hospital
• Esbjerg Hospital
• Viborg Regional Hospital
• Louis Pradel Hospital
• Hôpitaux de Marseille
• AP-HP Hopital Pitie-Salpetriere
• CHU de Nantes - Hôpital Nord Laennec
• Groupement de Cooperation Sanitaire (GCS) ESLAN - Polyclinique Vauban
• GHM les Portes du Sud
• Lausmed Kft
• DRC Gyógyszervizsgáló Központ Korlátolt felelősségű társaság Balatonfüred
• Debreceni Egyetem Klinikai Kozpont
• Kardiologia Szakrendeles
• Dr. Vasas Szilard Haziorvosi Rendelo
• Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• The Lady Davis Carmel Medical Center
• Shaare Zedek Medical Center
• Rabin Medical Center
• The Chaim Sheba Medical Center
• Policlinico di Sant'Orsola
• Asst Grande Ospedale Metropolitano Niguarda
• Ospdale E. Bassini
• Department of Translational and Precision Medicine
• Academic Medical Center
• Gelre Ziekenhuizen
• Ziekenhuis Rijnstate
• Ziekenhuis Gelderse Vallei
• Bethesda Diabetes Research Center
• Radboud UMC
• University Medical Center Utrecht
• New Zealand Clinical Research
• Edgar Diabetes and Obesity Research Centre
• The Lipid Clinic (Oslo University Hospital)
• Centrum Medyczne Salvia
• Clinical Best Solutions
• Centrum Zdrowia Metabolicznego Pawel Bogdanski
• Przychodnia Futuremeds Wroclaw
• Hospital Infante D. Pedro
• Centro Hospitalar Universitario De Sao Joao
• Kardiologická ambulancia
• Cardio D&R, S.R.O. Kosice
• Interna SK, s.r.o., Kardiologicka a interna ambulancia
• Areteus sro
• Latros International
• TREAD Research
• Medi Clinic Vergelegen
• University of Cape Town
• Hospital Clinic de Barcelona
• Hospital Universitari de Bellvitge
• Hospital Universitario Reina Sofia
• Hospital Abente y Lago
• Hospital Universitario 12 de Octubre
• Corporacio Sanitaria Parc Tauli- Hospital de Sabadell
• Hospital Virgen del Rocio
• Hospital Universitari Sant Joan de Reus
• Sahlgrenska, University Hospital
• Karolinska University Hospital Huddinge
• Hacettepe Üniversitesi Tıp Fakültesi
• Hull Royal Infirmiry
• Oak Tree Surgery and Pensilva Health Centre
• Centre for Diabetes, Endocrinology and Metabolic Disease
• Huddersfield Royal Infirmary
• Metabolic Institute of America
• Excel Medical Clinical Trials
• Finlay Medical Research
• Columbus Clinical Services, LLC
• Innovia Research Center, Inc.
• Harmony Clinical Research, Inc.
• R & B Medical Center LLC
• VICIS Clinical Research
• JSV Clinical Research Study, Inc.
• Bayside Clinical Research
• IACT Health
• Centricity Research
• Affinity Health
• St. Vincent Medical Group, Inc.
• University of Kansas Medical Center (KUMC)
• The Research Group of Lexington, LLC
• Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
• Grace Research, LLC
• IRC Clinics
• University of Michigan- Endocrinology & Metabolism
• Aa Mrc, Llc
• Washington School of Medicine
• Modern Medical
• The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
• Kenneth Hilty
• Clinical Trials of America, LLC
• Central Oklahoma Early Detection Center
• Walker Family Care
• Monument Health Clinical Research
• Health Concepts
• University of Texas Southwestern
• Juno Research
• Pioneer Research Solutions
• DCT- McAllen Primary Care, LLC
• Texas Institute of Cardiology
• Southern Endocrinology Associates
• SMS Clinical Research, LLC
• Permian Research Foundation
• Diabetes & Glandular Disease Clinic, P.A.
• Tranquil Clinical and Research Consulting Services
• Manassas Clinical Research
• York Clinical Research
• WVU Heart and Vascular Institute

Participation Criteria

Eligibility criteria, ages eligible for study, accepts healthy volunteers, description.

Inclusion Criteria:

• Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 (last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgment.
• Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines.

Exclusion Criteria:

• Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria.

NOTE: Other Inclusion/Exclusion criteria may apply.

How is the study designed?

Design details.

• Primary Purpose : Treatment
• Allocation : N/A
• Interventional Model : Single Group Assignment
• Masking : None (Open Label)

Number of Arms

Arms and interventions.

What is the study measuring?

Primary outcome measures.

Collaborators and Investigators

Study record dates, study major dates, study start (actual), primary completion (estimated), study completion (estimated), study registration dates, first submitted, first submitted that met qc criteria, first posted (actual), study record updates, last update posted (actual), last update submitted that met qc criteria, last verified, more information, terms related to this study.

• ISIS 678354

Additional Relevant MeSH Terms

• Metabolic Diseases
• Lipid Metabolism Disorders
• Hyperlipidemias
• Dyslipidemias
• Hypertriglyceridemia

Other Study ID Numbers

• ISIS 678354-CS15
• 2022-501999-26-00 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to share individual participant data (ipd), drug and device information, study documents, studies a u.s. fda-regulated drug product, studies a u.s. fda-regulated device product.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected] . As soon as a change is implemented on clinicaltrials.gov , this will be updated automatically on our website as well.

Clinical Trials on Severe Hypertriglyceridemia

• Arrowhead Pharmaceuticals Completed Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia (SHASTA-2) Severe Hypertriglyceridemia United States, Netherlands, Australia, Canada, New Zealand, Poland, Hungary, Germany
• AstraZeneca Completed Epanova® for Lowering Very High Triglycerides (EVOLVE) Severe Hypertriglyceridemia United States, Hungary, India, Russian Federation, Denmark, Ukraine, Netherlands
• AstraZeneca Radiant Research Completed Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation (ECLIPSE) Severe Hypertriglyceridemia United States
• Trygg Pharma, Inc. Unknown Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia Severe Hypertriglyceridemia United States
• Arrowhead Pharmaceuticals Recruiting Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia (SHASTA-3) Severe Hypertriglyceridemia United States, Canada
• 89bio, Inc. Recruiting To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (ENTRUST) Severe Hypertriglyceridemia United States, Bulgaria, Canada, Latvia, Spain, Austria, Belgium, Czechia, Georgia, Hungary, Poland, Puerto Rico, Argentina, Chile, France, Germany, United Kingdom, India, Italy, Mexico
• Ionis Pharmaceuticals, Inc. Active, not recruiting A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia Severe Hypertriglyceridemia Finland, United States, France, Israel, Netherlands, Denmark, Spain, Australia, United Kingdom, Germany, Italy, Canada, Czechia, Turkey, Hungary, Bulgaria, New Zealand, Sweden, South Africa, Poland, Norway, Portugal, Slovakia
• Sancilio and Company, Inc. Withdrawn The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL) Severe Hypertriglyceridemia
• Zhejiang Doer Biologics Co., Ltd. Recruiting A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia Severe Hypertriglyceridemia China
• Arrowhead Pharmaceuticals Recruiting Study of Plozasiran in Adults With Severe Hypertriglyceridemia (SHASTA-4) Severe Hypertriglyceridemia United States

Clinical Trials on Olezarsen

• Ionis Pharmaceuticals, Inc. Completed A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants Healthy Participants United States
• Ionis Pharmaceuticals, Inc. Available Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) Familial Chylomicronemia Syndrome United States
• Ionis Pharmaceuticals, Inc. Active, not recruiting A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS) Familial Chylomicronemia Syndrome Spain, United Kingdom, France, Canada, United States, Italy, Netherlands, Norway, Portugal, Slovakia, Sweden
• Ionis Pharmaceuticals, Inc. Active, not recruiting A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia Cardiovascular Diseases | Atherosclerosis | Hypertriglyceridemia United States, Spain, Italy, Denmark, Hungary, Netherlands, Canada, France, Poland, Bulgaria, Czechia, Portugal, Slovakia, Norway
• Ionis Pharmaceuticals, Inc. Active, not recruiting A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen Familial Chylomicronemia Syndrome United States, Canada, Sweden
• Ionis Pharmaceuticals, Inc. Active, not recruiting A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia Severe Hypertriglyceridemia United States, Netherlands, Spain, France, Belgium, Italy, Greece, Slovakia, Bulgaria, Canada, Brazil, Malaysia, India, Poland, Mexico, Hungary, Taiwan, Argentina, Czechia, Portugal, Lithuania, Romania, Sweden
• Ionis Pharmaceuticals, Inc. Akcea Therapeutics Completed A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) (BALANCE) Familial Chylomicronemia Syndrome United States, Israel, Spain, Italy, United Kingdom, Netherlands, Canada, Hungary, Sweden, France, Norway, Portugal, Slovakia
• Ionis Pharmaceuticals, Inc. Completed A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia Hypertriglyceridemia | Atherosclerotic Cardiovascular Disease | Severe Hypertriglyceridemia United States, Canada

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Sponsors and Collaborators

• Department of Gastroenterology, Clinical Emergency Hospital of Bucharest, Romania
• Reema A. Patel
• Royal Adelaide Hospital, Australia
• Qingdao University
• NeuroTherapia, Inc.
• Fivenson, David, M.D.
• Alltech Life Sciences Inc.
• Jilin People's Hospital
• Ministry of National Development, Singapore
• Thrive Foundation
• Association for Social Development, Pakistan
• Sarah Thordsen
• General Hospital, Tianjin Medical University, Tianjin 300052, China.
• Cognitive Research Corporation
• Leids Universiteits Fonds
• Dutch Society of Pediatrics
• Manchester Academic Health Science Centre
• NVIDIA Corporation
• Menzies School of Health Research
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Medical Conditions

• Needs and Demands of Oncology Patients
• Regenerative Inflammation
• Vaccination Adverse Events
• Adult T-cell Leukemia
• Any Solid Tumor or Lymphoma
• Tinnitus, Hearing Loss, Cochlear Implant Users
• Inflammatory Marker
• Rhegmatogenous Retinal Detachment
• Acute Respiratory Decompensation
• Patch Testing
• Testosterone Greater Than 150 ng/dL
• Affective Disorders, Psychotic
• Kidney Transplant; Complications
• Physicians' Practice Patterns
• Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF)
• Temperature; Extreme, Exposure
• Myasthenia Gravis With Exacerbation (Disorder)
• Elderly Patiënts

Drug Interventions

• ARRY-380, HER2 inhibitor; oral
• Mitoxantrone
• Zoledronic Acid
• Ranibizumab injection alone
• NP-101 (TQ Formula)
• Dapagliflozin 10 MG [Farxiga]
• 25% human albumin
• Atorvastatin 20mg
• GRTA9906 60 mg PR tablet
• Paxlovid group
• Ertugliflozin OC Fast
• Linagliptin 5 mg QD
• LPS challenge with nebulized LPS
• Lopinavir/ritonavir
• SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron)
• Serplulimab
• Memantine Hydrochloride

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