Drug Safety Solutions (DDS) provide the depth and breadth of Operational support with physicians and scientists. Our team includes more than 2,000 staff located in the EU, USA, Japan, China and India supporting over 35 long-term clients. Our services to these clients span the full range of drug safety and pharmacovigilance (PV) services and also include advisory support on best practices in the management, sourcing and systems deployed in the safety arena. Our support is across five distinct pillars:
Clario DSS has deep expertise and experience from early phase studies to marketed products. With almost 50 years of experience, Clario has mastered collecting the reliable evidence needed to bring new drugs and therapies to market. Clario is a safe pair of hands to support clients in their current state while planning for your strategic objectives. Our PV SMEs, comprised of both physicians and scientists are end-to-end partners for our clients, proactively advising and collaborating in designing and maintaining PV services and systems which are fit-for-future.
- Approximately 900 of our employees have case processing experience and have processed over one million cases in the last twelve months. Our solutions are custom-built for your patients, indications and clinical trial objectives.
- We have over 150 physicians within the service line to support both clinical and post-marketing activities.
- Over 100 physicians and scientists form a part of our aggregate report writing group and have contributed to writing over 500 reports in the last 12 months (including Risk Management Plans (RMPs) and development RMPs).
- Over 50 physicians and scientists support in both qualitative and quantitative signal management activities supporting the generation of 8,000 workups and reports in the last twelve months.
- Over 500 employees are proficient in literature screening activities with a monthly average of 80,000 citations being reviewed.
- Clario is committed to transforming human health by supporting 70% of all new drug approvals from 2019-2020.
- End-to-end case processing which includes:
- Medical Triage
- Data Entry
- Quality review
- Medical review
- Reconciliation internally and externally with third parties
- Literature management
- Local literature screening
- Global literature screening
- EU QPPV services
- PV training
- PV Quality Assurance services, e.g., CAPA management
- Audit and inspection readiness including conducting internal and external audits
- Aggregate report writing:
- Including PSURs, PBRERs, DSURs. AdCos, PADERs
- Expedited reporting
- Signal management
- Risk Management Plan (RMP) and REMS writing
- Language capability
- Translation capability for 170+ languages across the globe delivered by our strategic partner
- In-house language capabilities for Portuguese, Spanish, French, German, Italian and Japanese
aggregate reports generated in the last 12 months
citations reviewed regularly
reports processed annually for signal detection
cases processed in the last 12 months
Our Medical Information (MI) subject matter experts SMEs, comprised of physicians, translators, healthcare professional (HCPs) and scientists are end-to-end partners for our clients, proactively advising and collaborating in designing and maintaining services and systems which are fit-for-future. Clario innovates the most effective trial models to help you meet the robust standards of evidence you need.
Our team has processed over 30,000 calls in the last twelve months. Clients are supported in an agile manner to support call volumes in a compliant manner. We support our clients in over 52 countries worldwide, in the language that is most comfortable to them. The intake of such a high volume of calls has resulted in Clario proactively supporting our clients significantly in the Medical Information space including:
- Customer intake
- Customer follow-up
- Medical information
- Prepaid mailers
- Closure letters
- Call transfers
- Management and tracking of calls
calls received in the last 12 months
safety call center abandonment
Providing assistance throughout the development, approval and post-approval stages of a product’s lifecycle, we are actively engaged with regulatory and compliance bodies to define the next generation of security standards, and how they will impact the trial lifecycle. Our team has extensive experience in helping companies achieve the necessary preparation and compliance as required by the FDA, EMEA and other global regulatory bodies. Our solutions are customized to suit each client; ranging from supplementary support to a client’s existing team through to a complete outsourced regulatory affairs function.
- Regulatory consulting support
- Regulatory medical and technical writing
- eCTD services
- Strategic labelling
- Regulatory global submission — ensuring compliance to regulatory bodies
- Clario also has an in-house tool, RITRACE, a Regulatory Information Management portal, which provides a consolidated database of all regulatory intelligence information.
- Enabling clients to have access to all local regulatory requirements for both clinical and post marketing safety commitments
- Providing visibility on upcoming regulatory change to provide adequate time to assess the impact on operations and software used to perform the operations and plan and implement the necessary changes
- Allowing for timely, effective and auditable compliance to local, regional and global regulatory requirements
- We adhere to the strictest security, privacy and compliance standards to maintain the integrity and confidentiality of patient data. Our recent CyberVadis score of 925 demonstrates our commitment to data privacy and GDPR, data protection, third-party management and business continuity.
- Affiliate management
- Business planning and investment (e.g., due diligence)
- Patient centricity in drug safety
- Sourcing strategy
- Assessing and designing structures, resources and capabilities
- Drug Safety Road Map
- PV benchmarking
A key pillar of our delivery services is the use of proprietary technology enablers to improve workflow, efficiency and quality. Our IT team supports us in the continuous evolution and enhancement of our TRACE products which we design for our clients with our clients. By listening to patients, we design clinical trials based on issues and lifestyle factors important to them. This improves engagement and compliance, which leads to better evidence. The need to introduce IT within PV became a necessity as the demand for our clients grew extensively. Through this development, we leverage our bespoke TRACE products to support in real-time vendor oversight, performance management, KPI oversight, CAPA management, along with literature, aggregate report and signal management tracking, in line with clients’ corporate requirements.
- Trace Products
- RPA embedded services
- Client collaborations on RPA initiatives
For post-marketing drug safety surveillance, Clario provides:
- End-to-end pharmacovigilance services including receipt, processing and scientific analysis, submission and distribution of Individual Case Safety Reports (ICSRs)
- Global and local literature management
- Aggregate report generation, submission and distribution
- Signal management
- Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS) generation
- Preparation and maintenance of Pharmacovigilance System Master File (PSMF)
- Local and EU QPPV services
- Medical Information Contact Center (MICC) services and language capabilities
- PV quality assurance
- Local affiliate management
- TRACE products