Optimize your product by measuring and monitoring for long-term success.

 

At Innomar Strategies, we offer comprehensive solutions for managing drug safety, pharmacovigilance, and risk management throughout a product’s lifecycle. Our multi-disciplinary team offers complete pharmacovigilance and drug safety solutions that can be provided as a stand-alone service, or in combination with a patient support program or a third party logistics solution. We have partnered with pharmaceutical companies, in and outside of Canada, to deliver pharmacovigilance services that relieve clients of the hands-on obligations and legislative pressures of monitoring drug safety.  

We offer a live, dedicated bilingual call centre; adverse event and product quality complaint reporting and management; medical information services; and more. We partner with our clients to ensure our services are tailored to fit the specific needs of your company and product.

Expert Pharmacovigilance Support

Innomar Strategies offers a full suite of pharmacovigilance solutions that are turnkey, flexible and customized. We have a centralized team of highly-trained and knowledgeable PV professionals with extensive experience in developing and implementing Drug Safety and Medical Information programs, compliant with Health Canada and the ICH regulations. We partner with clients to find optimal, cost-efficient solutions that meet your business needs, and aim to exceed your established performance indicators. Our team also provides essential support to clients during all regulatory inspections including Health Canada, FDA and MHRA audits.

AE Reporting & Product Compliant Services

Our team of experienced drug safety specialists is expertly trained in the intake, processing and reporting of Adverse Events and Adverse Drug Reactions, SAEs/SADRs, Product Quality Complaints and Lack or Loss of Efficacy reports, in the post-marketing phase of the drug life cycle. We offer both foreign and domestic AE case processing managed in a validated safety database. We ensure all reporting is executed according to the exact specifications of the defined, client-approved SOP to deliver accurate and timely reporting to clients and health authorities.

Medical Information Services

We partner with our clients to develop customized Medical Information (MI) programs to meet the needs of your product, program and/or local and global requirements. Within the parameters of our client-approved SOPs, our MI specialists develop verbal and written standardized responses and FAQ documents for efficient and streamlined management of MI requests. We also offer customized responses for complex questions and literature searches. Our MI specialists provide support in both English and French, with translation services for 180 additional languages, if needed.

Risk Management Programs

For products that require risk management programs, Innomar Strategies offers full-service solutions to develop and implement Risk Management Plans (RMP) that include program maintenance and data transmission to health authorities and clients. Our risk management services can be implemented separately or alongside our patient support programs to ensure proper coordination of all RMP elements, including HCP and patient registration, patient education, mandatory testing coordination and data entry, and reminder/alerts for HCPs. We also offer development and implementation of patient education support, a HCP call centre, and patient monitoring checklists.

Periodic Safety Update Report (PSUR) Development

Innomar Strategies can prepare and submit periodic safety update reports (PSURs/PBRERs) as specified by health authorities. We will generate and submit the initial and subsequent PSUR documents according to the ICH E2C guidelines, and then the subsequent periodic PSURs at the frequency determined by Health Canada. We also offer a product information database to incorporate relevant epidemiology, literature, drug utilization and safety data.