StatForce is providing high quality medical writing services for Biotech, Pharmaceutical, Consumer Health and Medical devices companies across the Globe. Our team of well qualified and experienced Medical Writers have deep experience in writing Regulatory, Clinical and Scientific areas.
StatForce has a comprehensive understanding of various Regulatory guidelines such as ICH-GCP, FDA, EMA guidelines. Our team consisting of professionals with qualifications in Medical, Pharmaceutical, and other Life Science subjects (MD, PhD and Masters) has expertise across therapeutic areas.
StatForce Medical Writers can help you prepare clear, concise, and high quality reports and documents. Our writers undergo continuous training with professional organizations.
We have the capabilities to provide the following medical writing services:
Protocol Development
StatForce provides sponsors with extensive experience in the development of protocol for every phase in a global working environment. We know first-hand how patient care is delivered and how research integrates into clinical practice to provide sponsors with protocol designs that work at the site level, while still addressing the needs from a scientific perspective.
Our extensive therapeutic experience allows us to craft protocols for the most complex early Phase I programs, all the way through the open label observational research programs in the post-approval environment.
StatForce has the ability to obtain leading principal investigator feedback where it matters (i.e. how to overcome potential barriers) and apply this to information to the protocol development process. We utilize a classic format of “potential challenges” and “workable solutions” to go over in great detail each element of the protocol for our sponsors. From the scientific side, sponsors benefit from our extensive knowledge of research design and statistics. George Clinical has extensive experience in statistical methodology, adaptive analysis, and statistical models.
Clinical Study Reports for Phases I-IV
Clinical Study Reports developed by George Clinical are created through a collaboration between published scientific experts and medical writers experienced in the nuances of regulatory requirements and scientific publishing. Sponsors benefit from this added expertise. George Clinical authors know what crucial information editors require for publication and feature clear, concise writing accompanied by extensive tables of readily understandable, and relevant information. Abbreviated clinical study reports are also available.
Well-constructed clinical study reports facilitate a smooth transition to publication, serving as the source documents for future manuscripts, book chapters, and presentations.
Clinical/Statistical Reports
StatForce provides sponsors with expertise that extends from statistical thought leaders through to in-practice clinical research experience and meta-analysis of results by PhD level researchers. The result is relevant information that meets the most stringent review by regulators and the scientific community and the opportunity to develop and analyze future research questions. Augmenting the data itself are visual representations of the material that provide lay-observers with an immediate understanding of the material.
Medical devices and diagnostics play a crucial role in the detection, prevention and treatment of a wide variety of health issues. At StatForce, we recognize that the clinical trial and approval process for a device or diagnostic is different than the drug development landscape. To help navigate the terrain, we bring a top device CRO team of experienced and qualified professionals to support your study in this cutting-edge market segment.
StatForce has a deep understanding of the regulatory requirements, operational guidelines, and safety considerations to successfully advance your medical device or diagnostic product. We have an impressive record in conducting pilot, pivotal, and post-approval studies. StatForce has the expertise and resources to support your unique and complex developmental needs. For success in your medical device or diagnostic study – and to improve the health and extend the lives of patients worldwide – StatForce is your full service CRO partner.
Infectious diseases are caused by pathogenic microorganisms such as bacteria, viruses, parasites or fungi. They are often referred to as transmissible diseases, communicable diseases, or contagious diseases. No matter the form of transmission, these diseases can affect our world in pandemic proportions.
StatForce continues its strong commitment to stop the spread of infectious diseases. As a full-service CRO, we work with sponsors and investigators to manage, prevent, and find cures. Our teams are adaptable, knowledgeable, and cohesive, with strong site relationships to help deliver the best infectious disease CRO services. We have the extensive experience with related treatments and vaccines – including antivirals, antibiotics and antifungal compounds – to deliver pertinent, practical knowledge to move your trials forward.
StatForce experience as a Central Nervous System (CNS) CRO providing clinical research is unrivaled. From neurology to analgesia and addiction drug development, our expertise spans translational medicine, registry with pharmaco-economic intent. Whether your compound is an original small molecule, injectable large molecule or biosimilar – our CNS experts are true specialists.
Developments in Cardiovascular research are resulting in a reduction of mortality and morbidity while new trends move toward identifying innovative study end points. Thus, new clinical trials related to Cardiovascular will need to be more nuanced.
The strategy for groundbreaking studies focused on Cardiovascular would be creating study designs with alternative end points, which are more nuanced than the traditional mortality end point and are both quantifiable and relevant to the needs of patients and to the interests of other medical care stakeholders.
Our history in cardiovascular research spans thousands of sites globally and has gathered data from hundreds of thousands of patients. This extensive history, combined with our capacity for innovative trial design and an understanding of cardiovascular research, makes us your ideal CRO partner in creative and strategic trial design for your heart failure study.
For the complexities of your hematological cancer study, StatForce Trials can apply a multidisciplinary approach with years of experience in oncology therapeutics research, including work on hematologic indications and therapies. As a full service CRO can provide any or all trial-related services, and we are just the right size to maintain the flexibility a complex trial requires and give your project the keen attention you expect.
We have diverse experience in various classes of small molecules and biologics across a broad spectrum of cancers, including lung, breast, skin, leukemias and multiple myeloma. Our deep experience goes even further, including: