This ensures the highest patient safety standards, on-site lab facilities, and quick, in-house access to all of the healthy volunteers and diverse patient populations you need through our global patient database.

At the start of a study, we swiftly recruit participants through our in-house database and established connections with top hospitals. Each study is supported by a dedicated project team comprising experts in project management, regulatory affairs, quality assurance, and scientific research. This team develops and implements a program tailored to your specific needs, which is then conducted in a state-of-the-art clinical facility.

We can even perform your Phase I trials across multiple locations at once, All to get you faster results and more accurate, useful data from First-in-Human through Proof-of-Concept, so your team has the information it needs sooner to continue with the next part of your journey.

Phase I services include:

• Full scope of Phase I clinical services
• Combination protocols
• Clinical pharmacology consulting
• Safety studies in target patient populations
• Comprehensive clinical data management services

Enhancing Your Experience by Optimizing Each Phase of Your Clinical Trials

From Proof-of-Concept to regulatory submission, Elevatia Solutions’ Phase II-III specialists optimize every aspect of your clinical trials. This approach smooths your journey, speeds up the process, and helps you manage the increasing size and complexity of pivotal research trials.

Our world-class clinical teams, experienced in handling complex Phase II and Phase III trials, work to reduce delays, errors, and costs. We enhance efficiencies and accelerate process speeds while ensuring the accuracy of performance data. Additionally, our extensive patient databases and network of trial sites across India enable us to maximize efficacy and expedite study startups.

We also collaborate with top experts in regulatory affairs, patient recruitment, database design, medical writing, clinical logistics, and more, to ensure comprehensive support for your trials.

Phase II – III services include:

• Complete clinical development services
• Full range of integrated eClinical technologies
• Advanced study start-up and patient recruitment strategies
• Proven site management metrics and best practices
• Access to high-value investigators
• Extensive therapeutic area experience

Additional Resources to Streamline Your Journey Pre- and Post-Approval

When it’s time to shift your development journey toward commercialization to gain first market access, Elevatia Solutions access can help you do it seamlessly, securely, and cost-effectively.

Elevatia Solutions, multi-disciplinary expertise, and integrated technologies to help you implement a market strategy that will quickly build your brand value and establish a strong market position – all while continuing to monitor your new drug’s long-term effects and manage related safety data and other regulatory information. At a time when exclusivity and patent protections are decreasing and regulatory demands are increasing, having a late phase specialist with world-class experience and resources to guide you through could extend your marketplace presence substantially.

Our Late Phase expertise helps simplify your journey using

• Dedicated Project Management Staff with global and local late phase experience.
• Local Market Penetration to customize solutions to the target market.
• Focused Site Management with PAN India remote monitoring capacity to manage costs.

Herbal/Neutraceutical Trials:

The rapid expansion of the natural product and dietary supplements sector necessitates clinical trials to validate safety and efficacy. Elevatia Solutions supports you at every stage of your clinical trial journey, helping you establish a unique position in the dietary supplement market, expand your market share, and differentiate your products. Our team of experts is dedicated to understanding your needs and providing solutions that comply with regulatory requirements.

Unlike drugs, which require premarket approval by the FDA, dietary supplements intended to affect the structure and function of the human body are not subject to approval under the Dietary Health Supplement and Health Education Act of 1994 (DSHEA). However, manufacturers must ensure their products are produced according to Good Manufacturing Practice (GMP) guidelines, accurately labeled, and free of contaminants. European Union (EU) regulations for supplements also support health benefits rather than therapeutic or medicinal claims. If a dietary supplement is intended to diagnose, cure, mitigate, prevent, or treat a disease, an Investigational New Drug (IND) application is required to conduct clinical investigations in humans

Real-world evidence/ Health Economics and Outcomes Research:

Biopharmaceutical manufacturers are turning to health economics and outcomes research (HEOR) to obtain real-world evidence (RWE) that can support and improve their drugs. Using HEOR to gather RWE helps biopharma companies address three forces reshaping how they do business:

• Competition in the biopharmaceutical manufacturing industry
• Interest from regulators, policymakers and patient advocacy groups
• Incentives from payers to enter into value-based contracts that base payment on outcomes

Medical Device Trials / Invitro Diagnostics CPE

• Elevatia Solutions lends support at every step of your clinical trial and conduct clinical investigations to assess the performance and safety of any class  of medical devices or clinical performance evaluation studies for invitro diagnostics.

In-House Clinical Trials

Elevatia Solutions lends support in Visting Patients’ House/preferred location for Better Enrolment, Compliance & Retention.

Based on Study Protocols – our SMO service can deploy trained and licensed service providers (nurses, technicians, clinicians) to organize house visits for:

• Study drug administration
• Taking biological specimens (e.g. blood samples for PK, safety tests etc.) swabs, urine etc.
• Clinical assessments e.g. vital signs (BT-BP-HR-RR), ECG etc.
• Patient counselling, education, and compliance checks.
• Patient diary updation etc.

 Providing this support enhances patient recruitment & compliance including patient retention.

Paediatric Trials

Right from Neonates to Teenagers – We have an experienced team in manage paediatric clinical trials and deeply understand the nuances, sensitivities, enhanced scrutiny and touchy issues.

End to End service includes:

• Study conceptualization in line with your specific objectives
• Development & production of study documents including Protocols, ICD & CRFs
• Regulatory affairs
• Study planning & organization
• Engaging Labs, Sites & Investigators
• Investigators’ meetings, project staff trainings
• Managing enrolments
• Logistics activities
• Hotline numbers & monitoring services
• AE/SAE, ADR/SADR information management
• Quality assurance & quality control, including monitoring & audit services
• Logical & medical review of CRFs
• Biostatistics, generation of study reports
• Manuscript writing and publication.