Clinical Research

The safety and efficacy of medications, devices, diagnostic products and treatment regimens intended for human use is studied under Clinical Research. It is the bloodline of all medical advances. We build smart, adaptable ways that take advantage of clinical-informatics, cutting-edge technology, and worldwide reach to improve research outcomes.

Our team consists of:

• Clinical scientists well versed in medical writing
• ICH-GCP certified professionals experienced in clinical trial
• Skilled-technicians working in clinics, laboratories and pharmacy
• Panel of doctors for expert opinion and peer reviews.

The Bone & Joint Research Centre is a centre of excellence in rare bone diseases. The centre is able to conduct phase 1 to 4 clinical research trials and is equipped with state-of-the-art monitoring facilities including cardiac monitors, EKGs as well as on-site imaging and lab facilities. The nursing staff are ICU trained and experienced and the facility can accommodate research studies requiring inpatient care. The following studies are currently being conducted at the Centre PaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism

A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men with Osteoporosis

SHP634-404 An open label study investigating the Safety and Efficacy of rhPTH-1-84 in subjects with hypoparathyroidism

SHP634-401 Study of the Effect of Recombinant Human Parathyroid Hormone [rhPTH(1-84)] on Symptoms Improvement and Metabolic Control Among Adults With Hypoparathyroidism

Efficacy of low dose Denosumab in maintaining bone mineral density in postmenopausal women with osteoporosis: a real world, prospective observational study

Physicians Advancing Disease Knowledge in Hypoparathyroidism patients with chronic hypoparathyroidism

Osteoporosis Treatment Rate Following Hip Fracture

Atypical Femur Fractures

Hypophosphatasia (HPP)

X-linked Hypophosphatemia Disease Monitoring Program – (XLH-DMP)

A Phase 3 Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Adolescent and Adult Participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

AUTOSOMAL DOMINANT HYPOCALCEMIA TYPES 1 AND 2 (ADH1/2) DISEASE MONITORING STUDY

PaTHway TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism

Clinical Trial Management

• Protocol Development 
• Project Management 
• Regulatory Services 
• Site Evaluation and Selection 
• Central Lab Services  
• Clinical Trial Supply Management  
• Site Management
• Medical Monitoring 
• Quality Assurance 
• Medical Writing  
• Statistical Analysis 

Clinical Data Management

• CRF design, printing & distribution 
• Database design & setup 
• Edit checks programming 
• Double data entry 
• Data validation & discrepancy management  
• Medical coding  
• SAE reconciliation 
• Integration of third-party data  
• Database lock & archival  

Regulatory Affairs

We continuously monitor today’s complex and ever-changing global regulatory landscape to efficiently deliver quality regulatory services and submissions.

Our global presence enables us to bring a deep understanding of local regulatory requirements to every project, keeping your research on time and on budget.