Question: What is medical writing?
Answer: Medical writing entails writing about medical topics in a variety of ways depending upon the type of document that is requested. A medical writer can construct a document that individuals with no scientific or technical background can read as well as reports for health professionals, or documents for regulatory and state agencies such as the Food and Drug Administration (FDA).
Question: What type of documents are medical writers usually hired to write?
Answer: Medical writing is interactive in that companies specify the type of document to be written as well as the guidelines that the medical writer will use to compile the report. Typical documents that medical writers develop include: review articles, case reports, original research articles, safety reports, patient brochures, research proposals, and a wide variety of customized documents.
Question: Why is expertise in medical writing so important?
Answer: Any form of medical document needs to be credible, accurate, concise, and clear. CodeArc’s medical writers have the expertise that is required to produce high-quality documents which ensure that the information being presented is appropriate for the target audience, but is also written in a professional and ethical manner.
Question: How are the medical writers trained in CodeArc?
Answer: Our team complies with regulatory requirements for FDA, EMEA, others.
Our medical writers are trained on ICH GCP principles, Writing style guides (like AMA), reference managers like endnotes and medical dictionaries like MedDRA/ WHODD as necessary. There are also specific writers trained on publication-related standards like GPP, ICMJE , CONSORT, QUORUM, MOOSE, STARD, STROBE, TREND, ethical considerations in the conduct and reporting of research
Question: How about the Data Security?
Answer: We have physical security and bio-metric access control for server/archival rooms
We also have an efficient disaster recovery and business continuity planning. Security of clinical study data is ensured by use of Firewall, and TLS encryption for emails & IPSEC for business to business secure virtual private network (VPN)
