Clinical Research Organization, Regulatory, Scientific Writing Services

A  clinical research organization  conducts clinical trials and testing on drugs developed by the  pharmaceutical companies  before they’re introduced into the marketplace for commercial use. Following are the phases of a clinical trial: • Phase 0: small dose of a drug on limited number of in-patients • Phase I: observing the consequences of various drug dosage on a gaggle of 20-40 people to seek out the perfect dosage capacity • Phase II: trial to guage and compare the effect of the new drug as compared to the effect of existing drugs for an equivalent medical condition. This phase is usually administered on a wider scale (~3000 participants) • Phase III: trial after FDA approval of the drugs . It involves thousands of participants and may last for years. Apart from testing for the effectiveness of a drug, a clinical research organization also offers the next services to varied pharma and biotechnological companies:- •  Clinical data management •  Pharmaco...

To resolve any medical purpose or to diagnose any health related issues, the involvement of specific  Medical DeviceConsulting Services  is essential.  However, for different usage purpose different medical devices are available which differentiates its significant role in specific diagnoses.Hence, medical device manufacturers manufacture specific medical device s to detect specific disease.  Similar to the drug approval, the design of medical device also gets approval from Food and Drug Administration (FDA). Every medical device has to undergo evaluation test as to check its risk factors. Mostly low risk medical devices reach the market without the FDA approval, medium risk medical devices have to undergo test demonstration of the device to prove its safety for patients and later gets approval from FDA and enters the market (Medicare Payment Advisor Commision, 2017) . The FDA defines medical devices as instruments which are used to diagnose various diseases, ide...

Scientific writing skills involve conveying the necessary information about a technology in various fields of life sciences such as, biotechnology, medicine, and engineering for publication or to explore new ideas to educationalists, scholars, and other professionals. It conveys information on novel innovations and theories which is essential for publishing and marketing academic journals and so on.The purpose of scientific writing companies   is to provide the useful information on a paper to grab the attention of readers and to make them understand the content.  In any situation if the document fails to convey the appropriate information, the reader may not understand the concept which might lead to lose their interest to read (Cristian A. Linte, 2014) . However, every one cannot be a good scientific writer, often it is difficult to put the innovative ideas on paper to document and bring it to the reader.  The poor writing will erode reader’s co...

Medical writing Service s  is a specialized area of writing where the medical writer needs to develop different types of scientific documents that include research related documents in the field of medical science and associated regulatory areas.  The demand for competent, professional medical writers is growing at a rapid pace due to an exponential growth of pharmaceutical companies, diagnostic field and health care related portals, which require effective health care communication materials to promote their medicines, medical devices, related products and services to the doctors, patients and the general public.  MEDICAL WRITER Some Important Tips The following are the other important aspects that need careful consideration of medical writers to develop their competence in the field of professional medical writing. A competent medical writer will require a 1) Good understanding of various medical concepts commonly used medical abbreviations and rela...

G o beyond general document editing skills A  medical editor , who ensures the consistency of facts,  data and scientific  units and makes the manuscript clear and precise, should be technically meticulous more than general editing on spelling, grammar and punctuation errors in a manuscript. Medical Editing Services  – PEPGRA Acquire basic knowledge of different medical specialties Medical terminology and concepts are profoundly complex and highly technical. So, Subject knowledge is must when editing technical documents related to different  therapeutic areas  such as Cardiovascular Critical Care Dermatology Endocrine Gastroenterology Hematology & Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Rare Diseases Respiratory Urology Vaccine Development However, as it may not be possible for an editor to have knowledge in different areas, a medical editor should acquire basic knowledge in different...

Periodic Safety Update Reports (PSURs) are nothing but  pharmacovigilance Service s  documents that are intended to offer an assessment with regards to the risk-benefit balance of a specific medicinal product at time points that are predetermined, following its authorization. Periodic SafetyUpdate Reports (PSURs)  PSUR; What is it? Periodic Safety Update Reports (PSURs) are nothing but Pharmacovigilance Services   documents that are intended  to supply  an assessment with regards to the risk-benefit balance of  a selected  medicinal product at time points that are predetermined, following its authorization. The key idea of the PSUR is  to supply  an in depth  and vital evaluation of the risk-benefit balance of  the merchandise  , while taking into consideration novel or emerging information  associated with  safety  within the  context  of accelerating  information  conce...