Grand Pacific CRO (GPCRO) has a consistent track record of success as a full-service CRO coupled with our experience in ophthalmology studies. This means we have the flexibility to adapt to the unique requirements of each ophthalmology trial and the capacity to tailor your experience to best suit your goals. We maintain an extensive network of research and clinical ophthalmologists and opinion leaders who specialise in glaucoma, corneal, retinal, pediatric and general ophthalmology. These resources allow GPCRO to provide expert guidance and advice on ophthalmic clinical program development.

Areas of Expertise:

• Achromatopsia
• Choroideremia
• Cystoid Macular Edema
• Diabetic Macular Edema
• Diabetic Retinopathy
• Dry Age-Related Macular Degeneration (Dry AMD)
• Glaucoma & Neuroprotection
• Leber’s Congenital Amaurosis (LCA)
• Leber’s Hereditary Optic Neuropathy (LHON)
• Myopia Progression
• Proliferative Vitreoretinopathy
• Retinal Vein Occlusion (Branch [BRVO] and Central [CRVO])
• Retinitis Pigmentosa
• Retinoschisis
• Stargardt’s Disease
• Uveal Melanoma
• Uveitis (Anterior, Intermediate, Posterior)
• Vitreomacular Adhesion
• Wet Age-Related Macular Degeneration (Wet AMD)

Grand Pacific CRO (GPCRO) is able to deliver your infectious disease clinical trials with the best quality tailored to your requirements. GPCRO has the best solutions with time-saving and cost-effective options to fit your needs.

We understand the urgency, complexities, and potential challenges associated with infectious diseases which is why our team has extensive experience designing and conducting infectious disease clinical trials.

ANALYTICAL LABORATORY SERVICES GPCRO

GPCRO has more than 50 ISO 15189-accredited bioanalytical methods for the determination of anti-infectious disease drugs in various clinical trial samples (whole blood, serum, plasma, and urine) that are readily available for biosafety testing as well as Pharmacokinetic/Pharmacodynamic evaluation of comparators and interacting drugs. With experience in developing and validating new bioanalytical methods, GPCRO also provides services which include:

• Biosafety testing
• Pharmacokinetics/Pharmacodynamics evaluation
• Biomarkers
• Cell-based & Immunoassays
• Molecular and serology testing
• In-vitro drug susceptibility

Rare Disease clinical research studies pose a different challenge in terms of project management, site selection, and patient enrollment and retention. Rare diseases affect fewer than 200,000 patients at any given time and demand a full-service CRO with innovative strategies to manage a rare disease program. In particular, Rare Disease clinical research studies necessitate expertise in enrolling rare disease patients and maximising site selection to create realistic study feasibility. Designing protocols and executing study design for scarce patient populations, including pediatric patients who comprise 50% of these populations, requires medical doctors and pediatricians with specialised expertise. In addition, study design inclusive of a late phase component with access to Rare Disease patient registries is a critical tool.

Grand Pacific CRO (GPCRO) has the experience to design and conduct your rare disease clinical trial. Our experience includes, but is not limited to:

• Acromegaly
• Adrenocortical carcinoma (ACC)
• atypical Hemolytic Uremic Syndrome (aHUS)
• Cushing’s Syndrome
• Cystic Fibrosis
• Duchenne Muscular Dystrophy (DMD)
• Eosinophilic Esophagitis
• Familial Hypercholesterolemia
• Fibrodysplasia Ossificans Progressiva
• Gastroparesis
• Glomerulonephritis
• Growth Hormone Deficiency
• Lysosomal Storage Diseases
• Paroxysmal Nocturnal Dyspnoea (PND)
• Renal vasculitis
• Respiratory Syncytial Virus (RSV) in lung transplant patients
• Tinnitus
• TTR Amyloidosis
• Usher’s Syndrome

Grand Pacific CRO (GPCRO) has acquired a wealth of global trial experience across a variety of endocrine indications. Our team provides expertise in endocrine disorders, offering a range of services in imaging operations, statistics, and consulting for both the medical and laboratory landscapes. We provide therapeutic indication training to the project team to enable studies to get up and running promoptly and to meet aggressive project timelines.

Areas of Expertise:

• Homeostasis disorders
• Thyroid disorders
• Sex hormone disorders
• Growth hormone deficiency
• Hypogonadism
• Calcium homeostasis disorders and Metabolic bone disease
• Pituitary gland disorders
• Tumors of the endocrine glands not mentioned elsewhere

Grand Pacific CRO (GPCRO) provides many experts with a depth of knowledge based on experience across a range of neurologic disorders. Our clinical trial experience in neurology enables us to work with you at any stage of drug development, from Phase I through Phase IV, for traditional as well as highly innovative clinical targets.

GPCRO has extensive capabilities and therapeutics experience in neurology research. Our clinical monitors and project management team are exceptionally familiar with the use of appropriate diagnostic and outcome measures to evaluate a variety of neurology clinical trials.

GPCRO SERVICES  

• Development of regulatory strategy, expedited pathways and regulatory agency interactions
• Clinical program planning, inclusive of statistical planning and analysis
• Participant recruitment strategies to support clinical trials
• Rapid deployment of clinical trial databases
• Clinical and medical site monitoring
• Data analysis
• Writing of clinical trial, safety, and regulatory documents
• Complete clinical trial services, program management and support
• Clinical trial strategic consulting
• Clinical primary site testing
• Analytical and clinical testing services
• Complete data management program support

Along with our pre-clinical CRO services, Grand Pacific CRO (GPCRO) offers consulting services adapted to the specific needs of our clients. Our metabolic diseases experts offer their many years of experience in drug development to help you design and run efficient and cost-effective studies that shorten your product’s time to market. With over a decade of expertise in metabolic diseases, GPCRO ensures the highest standards are applied for the design, conduct, and analysis of all studies. Our team has hands-on experience with a wide range of testing procedures and models to detect early signals of safety or efficacy that support better decision making and delivery of efficient drug development programs for you. Specifically, our in-depth knowledge of diabetes and obesity studies ensures the best practices are applied to provide high-quality data that adheres to FDA, TGA and EMA guidelines to support regulatory filings.

Areas of Expertise:

• Diabetes (Type 1) and diabetes (Type 2).
• Gout
• Growth disorders
• Dyslipidemia
• Hypogonadism
• NASH (Non-alcoholic Steatohepatitis)
• Obesity