Our Services

Jupiter Global offer a flexible Functional Service Provider (FSP) model. This approach allows clients to outsource specific functions or services as needed, providing tailored solutions to their unique requirements.

Our FSP services include:

• Site Management & Patient Recruitment: Overseeing clinical trial sites and recruiting eligible patients.
• Qualification Audit: Assessing the suitability of clinical trial sites and investigators.
• Monitoring: Conducting regular site visits to ensure compliance with study protocols and data quality.
• Regulatory Services: Providing guidance and support with regulatory submissions and approvals.
• Data Management: Collecting, cleaning, and managing clinical trial data.
• Statistical Support: Providing statistical analysis and interpretation of clinical trial data.

By leveraging our FSP model, clients can benefit from our expertise in specific areas while maintaining control over other aspects of their clinical trials. This approach offers flexibility, efficiency, and cost-effectiveness.

Effective project management is essential for the successful execution of clinical trials. We are proud to offer expert project management services that ensure:

• Quality: Delivering high-quality research outcomes that meet the highest industry standards.
• Accuracy: Ensuring data integrity and accuracy throughout the trial process.
• Timelines: Adhering to project timelines and milestones to meet key deliverables.
• Commitment: Delivering on our commitments to clients and stakeholders.

Our project management team provides comprehensive oversight, coordination, and risk management to ensure the smooth and efficient conduct of clinical trials. We work closely with clients to develop and implement tailored project plans that align with their specific goals and objectives.

Jupiter Global Bio-Research offers comprehensive site management solutions to support the efficient conduct of clinical trials. Our services include:

• Site Feasibilities: Assessing the suitability of potential clinical trial sites based on various factors, including geographical location, infrastructure, and investigator expertise.
• Site Development: Providing support for the development and preparation of clinical trial sites, including obtaining necessary approvals and ensuring compliance with regulatory requirements.
• Site Selection: Identifying and selecting the most appropriate clinical trial sites based on study objectives and feasibility assessments.
• Site Coordination: Managing and coordinating activities at clinical trial sites, including investigator training, patient recruitment, and data collection.

Study Start-Up Activities

In addition to site management, we also provide essential study start-up activities to ensure a smooth and timely initiation of clinical trials. These services include:

• Regulatory Submissions: Assisting with the preparation and submission of regulatory documents to obtain necessary approvals.
• Investigator Training: Providing training and education to investigators and site staff on study protocols, procedures, and regulatory requirements.
• Informed Consent Development: Developing and obtaining informed consent documents from study participants.
• Patient Recruitment Strategies: Implementing effective patient recruitment strategies to enroll eligible participants.
• Site Initiation Visits: Conducting initial site visits to assess readiness and ensure compliance with study protocols.

By providing comprehensive site management and study start-up services, Jupiter Global Bio-Research helps clients streamline the clinical trial process and achieve their research objectives.

We offer customized corporate training programs designed to enhance the knowledge and skills of your site staff and company employees. Our experienced trainers provide comprehensive training on essential guidelines and regulations, including:

• ICH (International Conference on Harmonisation): Ensuring compliance with international standards for clinical research.
• GCP (Good Clinical Practice): Adhering to ethical and scientific principles in clinical trials.
• GLP (Good Laboratory Practice): Maintaining quality and integrity in non-clinical laboratory studies.
• Protocol Training: Providing in-depth understanding of specific clinical trial protocols and procedures.
• Study Specific Training: Tailoring training programs to address the unique requirements of individual studies.

Our training programs are designed to empower your team with the necessary knowledge and skills to conduct clinical trials efficiently, ethically, and in compliance with regulatory requirements.

We provide comprehensive procurement, sourcing, and logistics services to support your clinical trials. Our expertise includes:

• API (Active Pharmaceutical Ingredient) Procurement: Sourcing high-quality APIs that meet the stringent requirements of your clinical trials.
• API Intermediate Sourcing: Procuring essential intermediates used in the manufacturing of APIs.
• IMP (Investigational Medicinal Product) Procurement: Sourcing investigational drugs and formulations for clinical trials.
• Standards Procurement: Obtaining reference standards and control materials necessary for quality assurance.
• Trial Materials Procurement: Sourcing other essential materials required for the conduct of clinical trials.

In addition to procurement, we also offer efficient logistics solutions:

• Fast, Temperature-Controlled Shipments: Ensuring the safe and timely delivery of temperature-sensitive materials worldwide.
• Global Supply Chain Management: Managing complex supply chains to meet the specific needs of your clinical trials.
• Inventory Management: Tracking and managing inventory levels to avoid stock outs or excess inventory.

Our goal is to streamline the procurement and logistics processes for our clients, allowing them to focus on conducting high-quality clinical trials.

Jupiter Global Bio-Research offers specialized and precise services in In-Vitro Release Testing (IVRT) and In-Vitro Permeation Testing (IVPT), providing clients with comprehensive solutions for topical formulation development and regulatory compliance.

Our focused services include:

IVRT & IVPT Studies: Delivering in-depth analysis of drug release and permeation profiles for topical products.

• In-Vitro Release Test (IVRT): Utilizing synthetic membranes to assess the rate and extent of drug release from topical formulations.
• In-Vitro Permeation Test (IVPT): Employing human cadaver skin to evaluate the permeation of drug substances through the skin barrier, providing crucial insights into bioavailability.

Technical Expertise & Equipment:

• We utilize state-of-the-art Vertical Diffusion Cells (Franz Cells) for accurate and reproducible IVRT and IVPT studies.
• Our services cater to a wide range of topical formulations, including gels, lotions, ointments, and creams.

Regulatory Compliance & PSG Expertise:

• We possess extensive experience in conducting IVRT and IVPT studies in alignment with USFDA Product-Specific Guidances (PSGs).
• Our expertise covers numerous USFDA PSGs, including but not limited to: Adapalene, Acyclovir, Clindamycin phosphate, Calcipotriene, Dapsone, Diclofenac sodium, Ivermectin, Mupirocin, Penciclovir, Silver sulfadiazine, Sirolimus, Tacrolimus, and Tazarotene.

By entrusting your IVRT and IVPT studies to [Your Company Name], clients gain access to specialized knowledge, advanced equipment, and meticulous adherence to regulatory standards. We provide reliable data and comprehensive reports, supporting your product development and regulatory submissions with precision and efficiency.

Jupiter Global Bio-Research specializes in comprehensive In Vitro Feeding Tube Studies, providing critical data for drug product administration via nasogastric (NG) and gastrostomy (G) tubes.

Our focused services include:

NG & G Tube Studies: Conducting rigorous testing to evaluate the suitability and performance of drug products administered through feeding tubes.

• We analyze the drug product's behavior when administered through NG and G tubes, ensuring accurate delivery and consistent performance.
• Our studies encompass a variety of oral dosage forms, including tablet products, oral suspensions, and capsules containing pellets, granules, or beads.

Technical Expertise & Equipment:

• We utilize specialized NG Tube Apparatus, including tubes, tube platforms, and camera systems, to simulate real-world administration conditions.
• Our testing protocols are designed to assess drug product integrity, dissolution, and potential interactions with feeding tube materials.

Regulatory Compliance & PSG Expertise:

• We possess in-depth knowledge of USFDA Product-Specific Guidances (PSGs) related to feeding tube administration.
• Our expertise covers a wide range of USFDA PSGs, including but not limited to: Dexlansoprazole, Lansoprazole, Apixaban, Rivaroxaban, Gefitinib, Ticagrelor, Mycophenolate Mofetil, Baclofen, Carglumic acid, Baricitinib, Esomeprazole magnesium, Pantoprazole sodium, and Omeprazole magnesium.

By partnering with [Your Company Name] for your In Vitro Feeding Tube studies, you gain access to our specialized expertise, advanced equipment, and commitment to regulatory compliance. We deliver precise and reliable data, supporting your drug product development and ensuring safe and effective administration through feeding tubes.

Jupiter Global Bio-Research offers comprehensive In Vitro Binding Studies, providing critical insights into drug-receptor interactions and product performance.

Our focused services include:

In Vitro Binding Studies: Conducting detailed analyses of drug binding characteristics to support product development and regulatory submissions.

• In-vitro equilibrium binding study: Determining the affinity and capacity of drug binding at equilibrium, providing essential data for understanding drug-receptor interactions.
• In-vitro kinetic binding study: Analyzing the rates of drug association and dissociation, revealing the dynamic aspects of drug binding and informing pharmacokinetic and pharmacodynamic models. 
• We can perform these studies on a variety of formulations including powders, suspensions, and tablets.

Technical Expertise & Regulatory Compliance:

• We utilize established methodologies and state-of-the-art equipment to ensure accurate and reliable binding data.
• Our expertise encompasses a range of USFDA Product-Specific Guidances (PSGs), including but not limited to: Cholestyramine HCl, Colesevelam HCl, Colestipol. Sucralfate Suspension and Tablet, Sevelamer Carbonate, Sevelamer HCl, Sucroferric oxyhydroxide, Ferric citrate, and Lanthanum carbonate.
• We adhere to stringent quality standards and regulatory guidelines, ensuring the integrity and reliability of our study results.

By partnering with [Your Company Name] for your In Vitro Binding Studies, you benefit from our specialized expertise, advanced technology, and commitment to regulatory compliance. We deliver precise and comprehensive binding data, supporting your product development and ensuring regulatory success.