Pharmaceutical

MRC acts as an overflow solution for CROs and pharmaceutical safety departments seeking assistance with the receipt of adverse event data and population of MedWatch forms for submission to the FDA.

MRC’s safety nurses monitor adverse events and product complaints from multiple sources to assess, categorize, and characterize complex information.

Incoming consumer or healthcare provider calls may be routed to MRC’s nurse-staffed call center to be screened for reportable adverse events. Pertinent information will be collected and entered on a standard intake form during this initial call, reducing the length and number of interactions required for a complete adverse event report.

Written adverse event reports may be received and processed through MRC’s Records Management Intake division.

In the case of Serious Adverse Events (SAEs) and/or Serious Unexpected Adverse Events, MRC’s team of nurses can supplement the data captured in MedWatch forms with SAE Narrative Writing.

MRC’s SAE Narrative Writing includes:

– In-depth medical record review

– Summarization and highlight of relevant clinical information

– Concise and comprehensive narrative report presented in chronological sequence

– Report submission directly to the FDA on client’s behalf, or delivered to clients in their preferred formats

– Assigned nurse staff who possess significant critical care experience and knowledge across a wide variety of clinical specialties

For over three decades, MRC has supported the pharmaceutical industry by providing litigation teams and in-house counsel with valuable support in the form of our medical record review and analysis.

Our team of experienced, knowledgeable nurses analyzes the medical story surrounding the legal situation a pharmaceutical company is facing.

MRC nurses will comb through the claimant’s complex medical history and will provide an in-depth interpretation of the medical facts affecting the case, which a pharmaceutical company’s legal, pharmacovigilance, and drug safety departments can then use to present a strong defense.

MRC offers comprehensive Medical Literature Research and Analysis, conducted by MRC nurses who are experts in research techniques and are deeply familiar with scientific and medical terminology, as well as the legal process.

Pharmaceutical industry clients who utilize our Medical Literature Research solution will benefit from a thorough review and expert analysis of published clinical research findings. Armed with MRC’s Medical Literature Research work product, clients will have the medical evidence they need to present a strong case, as our nurses will research and present clients with their factual findings and their expert interpretation of the medical precedent, the full extent of medical damages, the plausibility of causation, research on chemicals’ exposure routes, their causation to illnesses, symptomatology, and more.

MRC provides clients with fast, safe, and accurate record retrieval services.

We collect all record types via multiple methods, including: fax or mail, electronic document retrieval, subpoena, and on-site scanning.

Our flexibility provides clients with the fastest possible turnaround time, an average of less than 30 days for most record types.

Our world-class record retrieval and document management system provides users with 24/7 access to organized records and an unparalleled level of security and transparency throughout the record retrieval process.

We provide HIPAA-compliant document management, fulfillment, and shipping, ensuring all records are transferred quickly, safely, and effectively.

Clients across the pharmaceutical industry can take advantage of MRC’s professional, RN-staffed call center.

Our experienced, customer service-oriented call center staff helps MRC customers to effectively handle incoming calls. They have the answers and guidance callers need and can handle highly complex calls, all the while establishing rapport between the caller and MRC’s client.

MRC customizes call center solutions according to the individual needs of each client.