Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
Documents translated – Participant ID Card, Patient Brochure, Participant Study Guide, Physician Referral Letter
Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults.
Documents translated – COVID-19 Vaccine Banner, Clinical Trial Posting Letter, Dr to Participant Letter, Participant ID Card, Patient Brochure, Participant Study Guide, Physician Referral Letter, Print Ads, Social Media materials.
For an investigational medication for people with relapsing multiple sclerosis (RMS), including people with relapsing-remitting MS (RRMS) and people with secondary progressive MS (SPMS) with relapses.
Documents translated – Patient Emergency Card, Participation Diary, Participants’ Study Guide.
Compares the efficacy and safety of Otilimab with placebo and with Sarilumab, all in combination with conventional synthetic DMARDs, over 24-weeks in approximately 500-600 patients with moderately to severely active RA who have an inadequate response to biological DMARDs and/or JAK inhibitors.
Documents translated – Patient Study Guide, ICFs
A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin with Pomalidomide and Dexamethasone (B-Pd) Vs Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM).
Documents translated – Patient Brochure, Patient Study Guide, Doctor To Patient Letters, Patient ID Card, ICFs
A phase 3 Study to Evaluate the Efficacy and Safety of Givosiran, an Investigational RNAi Therapeutic Targeting Aminolevulinic Acid Synthase 1, in Acute Hepatic Porphyria Patients.
Documents translated – Referring Physician Letter, Letter To Patient, Patient Brochure, Referring Physician Study Fact Sheet, Study Overview, Study Welcome Booklet, ICFs
A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase III Study of First-Line Carboplatin and Paclitaxel in Combination with Durvalumab, followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer.
Documents translated – Welcome Guide, Letter To Referring Physician, Study Overview, Referring Physician Presentation, Patient Brochure, Patient Video Script and Title Frames, Referring Physician Study Fact Sheet.
Evaluating 2 mg Etrasimod in study participants with moderately to severely active ulcerative colitis (UC)
Documents translated – Patient Welcome Letter, AEs, SAEs, Email/letters to Participant, Screening Q&A.
To evaluate the safety and efficacy of two doses of GT005 administered as a single sub-retinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD)
Documents translated – Hospitalization Letter, Participant ID Card, Participant Instructions Booklet, SEs, SAEs, CRFs
A phase IIIB, multicenter, randomizes, double-blind, placebo-controlled, clinical efficacy study of BALOXAVIR MARBOXIL for the reduction of direct transmission of influenza from otherwise healthy patients to household contacts
Documents translated – Contact Card, Flyer, Patient Brochure, Poster, Referring Physician Study Fact Sheet, ICFs
A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults
Documents translated – Hospitalization Letter, Participant ID Card, Participant Instructions Booklet, ICF, Dr. To Patient Letters, Public Facing notifications: Age Group Not Enrolling, Participant Journey Enrolment Closed, Study Email Communications, Potential Participants Call Script
To look whether the investigational medication, Filgotinib, has an effect on spermatozoa in men with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
Documents translated – Participant’s Welcome Letter, AEs, SAEs, Letters to Participant.
For studying the efficacy and safety of Lonafarnib/Ritonavir with and without Pegylated Interferon -Alfa-2a. It is a Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID With and Without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared With PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected With Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)Ide Therapy.
Documents translated – Fact Card, Log Sheet, ICFs, SEs, SAEs.
The Synchronize 301 and Synchronize 303 research studies are looking at a non-antibiotic investigational drug targeted for use with two of the most common forms of pink eye – those caused by certain viruses (adenovirus) or bacterial infection.
Documents translated – Patient Brochure, Referring Physician Study Fact, ICFs.
The three studies aim to find out if an investigational study drug called Mirikizumab can cause and maintain remission in people with moderate to severe Ulcerative Colitis that haven’t responded to previous or current Ulcerative Colitis medicines.
Documents translated – Doctor to Participant Letter, Participant ID Card, Patient Brochure, Participant Study Guide, Physician Referral Letter.
- Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism.
- Efficacy and safety of the investigational medication Edoxaban in children and young people who have confirmed Venous Thromboembolism.
- Edoxaban versus Warfarin for the Treatment of Atrial Fibrillation.
Documents translated – CRFs, ICFs, Participant Study Guide, Study Overview
Evaluation of Major Cardiovascular Events in Patients with, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo. The study will take place at approximately 1000 study centers in 30 countries. Approximately 12,600 adults with cardiovascular disease or who are at high risk for cardiovascular disease, have high cholesterol and have had complications related to taking statins, will take part in the study.
Documents translated – CRFs, ICFs, Patient Instructions Booklet.
These are a pair of international clinical research studies looking at how effective and safe a new investigational medication is for treating people with chronic heart failure.
A. The EMPEROR-Preserved Study: This is for people with a type of heart failure called preserved ejection fraction. It is titled Empagliflozin outcome trial in patients With chronic heart failure with preserved ejection fraction.
B. The EMPEROR-Reduced Study: People who have a different type of heart failure called reduced ejection fraction will take part in Empagliflozin outcome trial in patients with chronic heart failure With reduced ejection fraction.
Documents translated – Participants’ Study Guide, Fact Card, ICFs, SEs, SAEs
A phase III binary, parallel group, multi-sitecentric study to compare the performance and safety of Xluken v. Lucentis® among patients suffering from Neovascular age-related macular degeneration.
Documents translated – Screening Q&A, ICFs, CRFs.