Medicine for old people

Developing effective and safe medications for older adults presents unique challenges due to the complexities of aging and age-related health conditions. At Safe Vigilance, we provide specialized Geriatric Medicine Services designed to support the development and management of medications for older populations. Our experienced team offers end-to-end solutions to ensure that treatments are safe, effective, and suited to the needs of elderly patients.

1. Geriatric Clinical Trial Design and Management

Optimize the design and management of clinical trials for older adults with our expert services:
  • Protocol Development: Design clinical trial protocols that address the specific health needs and considerations of older patients, including comorbidities and polypharmacy.
  • Site Selection and Management: Identify and manage clinical trial sites experienced in treating geriatric populations, ensuring high-quality data collection and patient safety.
  • Patient Recruitment and Retention: Implement targeted strategies for recruiting and retaining older participants, including considerations for informed consent and adherence.

2. Age-Appropriate Formulation and Development

Ensure that your drug formulations are suitable for older adults with our development services:
  • Formulation Development: Develop and optimize formulations that address the physiological changes and potential sensitivities of aging, such as altered absorption and metabolism.
  • Dosing Adjustments: Establish appropriate dosing guidelines for older adults, considering factors such as renal and hepatic function, and potential drug interactions.
  • Stability and Packaging: Conduct stability studies and design packaging that facilitates ease of use and adherence for older patients.

3. Regulatory Affairs and Compliance

Navigate the regulatory landscape with expert guidance tailored to geriatric medicine:
  • Regulatory Strategy: Develop strategies for regulatory submissions specific to geriatric medicine, ensuring compliance with FDA, EMA, and other global regulatory requirements.
  • Pediatric and Geriatric Considerations: Address specific regulatory considerations for medications intended for older populations, including geriatric-specific guidelines and requirements.
  • Submission Preparation: Prepare and manage regulatory submissions, including INDs, NDAs, and marketing applications, with a focus on geriatric considerations.

4. Safety and Pharmacovigilance

Monitor and ensure the safety of treatments for older adults with our pharmacovigilance services:
  • Safety Monitoring: Implement robust safety monitoring systems to track and evaluate adverse events in older adult trials, paying close attention to age-related risk factors.
  • Pharmacovigilance: Conduct thorough pharmacovigilance activities to identify and assess safety signals specific to the geriatric population, ensuring timely reporting and risk mitigation.
  • Long-Term Follow-Up: Perform long-term follow-up studies to monitor ongoing safety and efficacy in older adults.

5. Market Access and Commercialization

Facilitate successful market access and commercialization of geriatric medicines:
  • Market Access Strategy: Develop strategies for market access, including pricing, reimbursement, and distribution plans tailored for geriatric products.
  • Health Economics and Outcomes Research: Conduct health economics and outcomes research to demonstrate the value and impact of treatments for older adults to payers and stakeholders.
  • Patient and Caregiver Education: Create educational materials and support programs for healthcare providers, patients, and caregivers to facilitate the use and adherence to new treatments.

6. Post-Market Surveillance and Support

Ensure the continued success and safety of geriatric medicines with post-market support:
  • Post-Marketing Studies: Conduct post-marketing studies to gather real-world data on the safety and effectiveness of treatments in older adult populations.
  • Adverse Event Reporting: Implement systems for monitoring and reporting adverse events, focusing on age-related safety concerns and drug interactions.
  • Regulatory Compliance: Maintain ongoing regulatory compliance and conduct periodic reviews to ensure continued market approval and adherence to updated guidelines.