medical information

Global Contact Center Support

ProPharma's Medical Information (MI) Contact Center services “follow the sun,” providing 24-hour services for pharmaceutical companies. Our team is comprised of experienced healthcare professionals (HCPs) and life science graduates who act as an extension of your team, communicating essential product information in the areas of drug/device information and product safety.

Bilingual Native Speakers

Our team of highly trained MI specialists includes bilingual native speakers in more than 35 languages. With 8 strategically positioned and globally integrated contact centers around the world, we can respond to medical inquiries in a manner that is not only consistent with product labeling and regulatory guidance, but also consistent with local evidence, culture, and communication styles.

Adverse Event Intake and Follow-up Services

ProPharma’s Medical Information (MI) team is trained on Adverse Event (AE) intake since onboarding as part of MI processing. We ensure that every AE is collected for patients’ safety, customer journey, and compliance at every contact center exchange and sent to the designated pharmacovigilance (PV) department. For a seamless experience, ProPharma offers comprehensive AE processing and reporting through our dedicated PV team to supplement or fully outsource your existing PV function.

Comprehensive AE Intake

Our skilled specialists follow established global processes and guidelines to obtain timely, accurate, and comprehensive AE information. ProPharma conducts refresher training, regular updates, and quality monitoring to ensure that every AE is detected and delivered to PV within 1 business day. Our AE collection forms can be customized for your needs in our fully validated database and our specialists are experienced with various client databases and AE forms.

Seamless Integration to Pharmacovigilance

All AE records automatically migrate from MI to the PV database within ProPharma, and you can review and monitor all cases from beginning to end in a single-point access 24/7. ProPharma can also integrate (E2B) with your PV database for the seamless and timely transfer of AE records.

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Product Complaint Intake and Follow-Up Services

ProPharma’s MI team is trained on Product Quality Complaint (PQC) intake since onboarding as part of MI processing. We ensure that every PQC is collected for patients’ safety, customer journey, and compliance at every contact center exchange and sent to the designated quality department. We are dedicated to supporting your customers and patients by handling every PQC and your company’s reputation with empathy and care.

Global Quality Serialization and Product Surety

We work collaboratively with our clients to offer centralized solutions for Global Quality Serialization and Product Surety (Level 5 Alerts). Our skilled staff have extensive experience with the alerts that are generated within the European Medicines Verification System (EMVS), detected by a national system, which are escalated to other stakeholders, including National Competent Authorities (NCAs) as they are generated. Our experienced team are also fully equipped to follow the process requirements for triage, follow-up, and closure of any Product Quality Serialization Verification requests. The intent of the requirements for reporting Level 5 Alerts set out in the Falsified Medicines Directive is to protect patient safety. Therefore, we ensure that our approach is pragmatic, effective, efficient, and solely focused on you and your patients.

Patient Support Programs

ProPharma partners closely with internal teams to support our clients’ customers and patients to provide first-in-class global Patient Support Programs. Our diverse team of global contact centers and field partners support patients and healthcare professionals worldwide in obtaining, understanding, and adhering to therapies for a well-rounded customer journey.

Provider Support

ProPharma supplies providers with materials for patient education, such as handouts and mock devices, to better serve their patients. We also provide helpful information to guide patients to therapy decisions by overcoming access or financial barriers. ProPharma is dedicated to ensuring that your customers are supported in all avenues.

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Medical Communications, Content Management & Translation

Medical writing is an essential part of clinical research, which requires expert knowledge to analyze and prepare complex regulatory documents.

ProPharma is a global leader in pharmaceutical consulting with over 35 years of experience, and our medical writing team has the expertise to assist with the development of your product. Our team of writers, editors, and quality reviewers knows what it takes to produce clear, concise text for your clinical, scientific, and regulatory needs.

No matter where you are in the development process, we can act as an extension of your team to support your initiatives and achieve successful outcomes.

Standard Document Creation

Our query management services include developing and updating libraries of standard response documents, sourcing and supplying clinical papers, and writing safety summaries. Our team of bilingual, native-speaking medical professionals can create or translate key standard documents in more than 35 local languages.

Custom Response and Content Management

Clients turn to ProPharma for quality and affordable custom response documents, delivered in a timely manner. Our team has experience in all therapeutic areas, with backgrounds in both the life science industry and academia. We provide a full range of content services, including literature research, writing custom response documents, and adapting documentation for use in other geographies.

Response Document Maintenance

We understand the importance of keeping your documents up to date with strict version control to provide the most accurate responses to inquiries. We work with your teams to take this burden off your hands, with efficient document management processes that our clients trust and rely on.

Medical Writing Services

From general guidance on strategy and formatting to specific projects like submissions and assessments — we can support your organization and adapt to changing needs throughout the development process.

Clinical and Nonclinical Medical Writing

• Benefit-risk assessments and Risk Management Plans (RMPs)
• Biologics License Applications (BLAs)
• Clinical Study Reports (CSRs) and narratives
• New Drug Applications (NDAs) (505)(b)(1) and 505(b)(2) submissions
• NDAs Modules 1-5
• Regulatory responses to questions
• Investigational New Drug Applications (INDs) and Investigational Device Exemption Applications (IDEs)
• Clinical Trials Disclosure (CTD) and authoring of plain language documents
• Chemistry, Manufacturing, and Controls (CMC) materials
• Drug Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Periodic Benefit-Risk Evaluation Reports (PBRERs)
• General investigational plans
• Informed consent forms
• Investigator’s Brochure (IB)
• Medical device Clinical Evaluation Reports (CERs)
• Pediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs)
• Lifecycle management
• Protocols and amendments
• Orphan Drug Designation (ODD)/Breakthrough Designation
• Pre-meeting packages (PMPs)/briefing packages
• Ethnic Sensitivity Reports
• Immunogenicity Reports

Project Support

• Compilation, hyperlinking, and publishing
• Comprehensive project management
• Content editing and proofreading: Including a QC review of data against text and source documents
• Style guide and template creation
• Literature searches, analysis, reference libraries, and citations
• Standard operating procedure (SOP) development
• Build figures and populate tables

Publications

• Abstracts, Manuscripts, and White Papers
• Continuing Medical Educations (CME) program planning
• Publication strategy

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