ABOUT US
Bioexel's mission is to be a Functional Service Provider (FSP) and CRO with global service delivery, world-class scientific leadership provides the full range of clinical trials services to pharmaceutical, medical device and diagnostic customers for all trial phases.
Bioexel enables our clients to access solutions even for their toughest clinical development and trial management challenges from early phase to complex late stage programs.
In today’s increasingly complex clinical development environment, life sciences companies are faced with pressures from regulators, payers, and the public to manage clinical trials that are safe, cost-effective, and informed by big data and technology. To ensure the best possible outcomes for their product, life sciences companies need a reliable, experienced partner who understands how to make insight-driven decisions at every stage of the clinical development pipeline
THERAPEUTIC EXPERTISE
Bioexel brings clarity to drug discovery around the world by helping biopharmaceutical companies solve some of today's most pressing challenges in oncology, inflammation, cardiovascular, CNS, Dermatology and many more Drug Discovery.
CNS
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Neurodegenerative Disorders (Alzheimer's Disease, Frontotemporal Dementia, Mild Cognitive Impairement, Traumatic Brain Injury and Parkinson's Disease), Autoimmune Neurological Disorders (Multiple Sclerosis), Neuromuscular Disorders, Epilepsy and Seizure Disorders, Pain Syndromes (Postoperative Neuropathic Pain, Post Therapeutic Neuralgia, Diabetic Neuropathy, Nerve Trauma and Migranes).
CARDIOVASCULAR
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Acute Coronary Syndrome (ACS), Angina, Arrhythmias, Atherosclerosis, Atrial Fibrillation, Congestive Heart Failure, Hypertension, Myocardial Infarction, Peripheral Artery Disease, Pulmonary Artery Hypertension, Stroke, Thrombosis.
DERMATOLOGY
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Atopic Dermatitis, Contact Dermatitis, Open wounds, Psoriasis, Urticaria, Systemic Sclerosis, Polymyositis, Cellulitis, Herpes.
ENDOCRINOLOGY AND METABOLISM
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Diabetes Type 1, Diabetes Type 2, Diabetes Complications (Diabetic foot ulcers, Diabetic nephropathy, Diabetic neuropathy, Macular edema), Hyponatremia, Hypophosphatasia, Male Hypogonadism, Molybdenum Cofactor Deficiency, Obesity, Renal disease, Grave's disease, Thyroiditis, Hypo and Hyperthyroidism.
ENT
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Acute Rhinitis, Allergy, Apergillosis, Auditory Loss and Deafness, Auditory stimulation, Barrett's Esophagus, Common Cold, Chronic Cough, Ear Infections,Nasal Obsturction, Oral Candidiasis, Otitis Externa (Swimmer's Ear), Otitis Media, Pnemonia, Sinus Infections, Strep Throat, Throat and Tonsil Infections, Tinnitus, Thymomas, Vestibular Hypofunction.
GASTROENTEROLOGY
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Inflammatory Bowel disease (Ceohn's Disease, Ulcerative colitis), Liver Disease (Non- Alcoholic Fatty liver disease, Non-Alcoholic Steatohepatitis, Irritable bowel syndrome, Gastro-esophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS), Constipation, Ulcers (Gastric and Duodenal/ H.Pylori, Diarrhea, Short Bowel Syndrome.
INFECTIOUS DISEASES
Bioexel has extraordinary skilled professionals to work on multiple studies includes: AIDS (Acquired Immune Deficiency Syndrome), Allergy, Anal Dysplasia, Chickenpox, Conjuntivities, Fever,Fungal Infections, Genital warts, Hepatitis, Genital Herpes, Human Papilloma Virus, Idoipathic Thrombocytopenic Purpura (ITP), Influenza, Meningitis, Osteomyelitis, Seborrhea, Sexually Transmitted Diseases (STDs), Smallpox, Systemic Fungal Infections, Viral Conjunctivitis, Viral infections, Warts, Yeast infections.
MEDICAL DEVICES
Bioexel has extraordinary skilled professionals to work on global medical device experience includes: Cardio vascular(Interventional and Gene Therapy), Respiratory (pulmonary embolism), Diabetes, Burns, Critical Care, Aesthetics, Obesity, Gastrointentinal, Women's health, Neuromodulation, Depression, Anxiety, Pain, Neurovascular, Opthamology (Lenses, IOL's), Orthopedic (Knee, Hip, Shoulder), Radiofrequency/ Ablation, Urology, Wound care and Diagnotics.
MENTAL HEALTH
Bioexel has extraordinary skilled professionals to work on multiple studies includes Depression, Bipolar Disorder, Post- Traumatic Stress, Anxiety, Psychosomatic disorders, Scizophrenia.
MUSCULOSKELETAL
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Acromegaly, Ankylosing Spondylitis, Arthritis, Bone marrow, Transplant, Bursitis, Carpal Tunnel Syndrome, Chronic Pain, Complex Regional Pain Syndrome, Connective Tissue diseases, Gout, Fibromyalgia, Joint injuries, Low Back Pain, Multiple Myeloma, Muscle Pain, Multiple Sclerosis, Muscular Dystrophy,Osteoporosis, Paget's Diseases, Myositis, Reflex Sympathetic Dystrophy, Sprains and so on.
ONCOLOGY
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Bladder Cancer, Brain Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Liver Cancer, Lung Cancer, Malignant Melanoma, Hepatocellular Carcinoma, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Renal Cancer, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Hogkin Lymphoma, Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma, Peripheral T-cell Lymphoma and Rare Oncology Diseases.
OPHTHALMOLOGY
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Cataract, Choroideremia, Conjuntivities, Diabetic Macular Edema, Dry eye, Eyelash Hypotrichosis, Glaucoma/OHT, Macular degenaration, Macular edema, Optic neuropathy, Retinal detachment, Uveitis and Vitreomacular Adhesion.
PAIN
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Cancer Pain, Post-Operative pain, Dental Pain, Low Back Pain, Migraine, Musculoskeletal Pain, Pain Management, Osteoarthritis Pain, Neurogenic Pain, Gynecological Pain.
RESPIRATORY
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Allergic Rhinitis, Asthma, Chronic obstrutive Pulmonary Disease (COPD), Cystic Fibrosis, Idiopathic Pulmonary fibrosis, Cystic Fibrosis, Bronchiectasis and Pulmonary Diseases.
UROLOGY
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Benign Prostatic Hyperplasia (BPH) / Lower Urinary Symptoms (LUTS), Erectile Dysfunction, Kidney/Renal Disease, Osteoporosis, Overactive Bladder, and Premature Ejaculation.
VACCINES
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Anthrax, Chickenpox (varicella), Cholera) Diptheria, flu, Hepatitis A, Hepatitis B, Hib (Haemophilis Influenza Type B), HPV Human Papilloma Virus), Measles, Meningococcal,Mumps, Pneumococcal, Polio, Rabies, Rotavirus, Rubella (german Measles), Shingles( Herpes Zoster), Smallpox, Tetanus, Typhoid Fever and Yellow Fever.
WOMEN’S HEALTH
Bioexel has extraordinary skilled professionals to work on multiple studies includes: Bacterial Vaginosis, Contraceptives, Endrometriosis, Gynecologic Surgery, Hypoactive sexual Desire disorder (HSDD), Female stress urinary incontinence, Minimally Invasive Surgery, Pelvic organ prolapse, Pregnancy, Sterlization and Uterine Fibroids.
SERVICES
Bioexel, we understand your need for speed of start-up and efficient progress before and during a study. With the responsive delivery plan, we can foresee and overcome any potential obstacles and create an accurate assessment of how we plan to deliver each study with full protocol compliance and medical evaluations
DATA MANAGEMENT
We are expertise in Clinical data management (CDM) in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. We pride ourselves on our ability to work on Clinical data management which ensures collection, integration and availability of data at appropriate quality and cost.
BIOSTATISTICS
Delivering accurate, high-quality and timely biostatistics services, including statistical planning, analysis and reporting. Staffed by highly experienced in-house biostatisticians and statistical programmers.
Biostatistics:
> Sample size calculations
> Statistical sections of the protocol
> Randomization schema
> Statistical analysis plans
> PK and PK/PD analyses
> Analysis of cardiac safety data (data from pilot and thorough QTc studies)
CLINICAL TRIALS
Accelerate your clinical development program. From project management through to clinical trial monitoring, management and patient recruitment. We’re one of the Asia-Pacific’s leading contract research organizations (CROs), and we have been for nearly two decades.
STATISTICS
Our expert Statistician have trained in current methods and standards to support complex clinical trials within national or international development projects or for marketed products as required. Assure well-designed clinical trials. Provide statistical expertise necessary to design, analyze, interpret and communicate the results of complex clinical trials. Provide statistical input for publications on clinical trials.
CLINICAL MONITORING
Our proficiency in the industry's top technology solutions allow us to provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.
PROJECT MANAGEMENT
It's Vital that your project is managed by people who have great proficiency in Clinical Project Management in providing customer-focused leadership and project oversight. We also facilitates communication among team members, including study monitors, sponsor personnel and the project Team. Our expert Clinical Project Managers proactively solves issues, and oversees the successful implementation and monitoring of clinical studies to ensure that studies are conducted in accordance with ICH/GCP and applicable regulations
DATA VALIDATION
Bioexel team have experts in Clinical Data validation on series of documented tests of the data with the goal of ensuring the quality and integrity of the data. Our validation is usually concerned with checking all data characteristics which are Attributable, Legible, Contemporaneous, Original, Accurate, Enduring, Complete and consistent.
MEDICAL WRITING
Our Medical writers develop documents from data sources in various analytic models for a variety of audiences, manage writing projects, and maintain consistency of style and message across multiple documents. They possess strong project management and negotiation skills and support projects with multiple customer contributors and external thought leaders.
Our Medical Writing Services Includes:
> Protocol development
> Study design consultation
> PK/PD reports
> Clinical summary reports
> Abstracts, posters, and manuscripts
REGULATORY SUBMISSIONS
A regulatory submission for a healthcare product includes any documentation or information submitted to a regulatory agency for review, for notification or in response to a request for additional information related to a healthcare product.
Bioexel team is led by professionals well experience in clinical research, product development, data standards, quality assurance, and regulatory affairs. We have completed numerous kinds of submissions, including INDs, clinical trial authorizations (CTAs), investigational medicinal product dossiers (IMPDs), and end-of-Phase II (EOP2) submissions. We understand the environment under which policies and practices evolve at the FDA and the European Medicines Agency (EMEA). Our vast experience and focus on quality has resulted in a 100 percent acceptance rate for submissions with the FDA.