Medical & Scientific Writing
Medical Writing
Medical Writing at Max Neo includes regulatory, marketing, and educational document writing services and we can undertake all medical writing services for Phase I to IV studies.
we are capable enough of writing SOPs and develop scientific posters and manuscripts as we have expertise in developing educational material as print form or web-based learning systems and promotional material for our clients' sales and marketing efforts.
Our medical writing team comprises of physicians who have experience in developing documents in various therapeutic areas such as oncology, cardiology, infectious diseases, ophthalmology, diabetes, neuropsychiatry and respiratory disorders. Documents prepared by us are in accordance with standard operating procedures and templates, and customized as per sponsor specifications.
Regulatory and Clinical Writing
- ICH GCP compliant Clinical Study Protocols; Phases II to IV,
- Investigator Brochures
- Patient information including Informed Consent and Patient Brochures
- Patient Diary Card
- Questionnaires and Assessments
- Clinical Study Report (CSR)
- Pharmacovigilance documents such as Periodic Safety Update Reports
- Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Contract Research Organization (CRO)
Scientific Writing
- Conference materials (abstracts, poster presentations and slide sets)
- Manuscripts
- Editorial support
- Journal/conference submission
- Product website content (for both scientific and patient audiences)
- Educational material for patients, healthcare professionals and pharmaceutical industry personnel
- Medical marketing reviews and reports
- Literature reviews
- Publication planning
Regulatory Services
The Max Neo Regulatory Affairs team has significant global experience in drug development and establishment of regulatory strategies. This endows our clients to develop their new drugs more efficiently and to accomplish timely and successful regulatory submissions.
Max Neo expertises in development of Dossiers, Drug Master File (DMF), and Common Technical Document (CTD).
Max Neo provides regulatory affairs consultancy tailored to meet client's specific needs. Client's data security and confidentiality is assured to the highest level.
We provide services from submission to final approval at the office of DCG(I), FDA Bhawan, New Delhi. We facilitate the guidelines for getting approval.
Biostatistics
Biostatistical services have always been a key component of Max Neo Clinical research services as part of our heritage. Our team has experience in all phases of research in clinical and post-marketing support across a wide range of therapeutic areas. Max Neo also provides all levels of support from bespoke consultancy for protocol design through to study level analysis of Tables, Listings and Figures.
Our biostatisticians have a desire for quality and implement the best approach to a client situation/scenario to ensure correct analysis without an over complex process. By using the appropriate tools, we are able to demonstrate the efficacy of a drug and present the results in the clearest way possible. We pride ourselves on our expertise and the ability to show clear results to our customers. We also take a personalised approach dependent on our clients needs which forms lasting partnerships and enables our experts to transfer their biostatistics knowledge on to our customers.
Max Neo is renowned for our employees’ depth of experience in biostatistics. Typically, our statistical consultancy services focus on protocol design, calculation of sample sizes, power calculations, and/or the production of a study randomization.
Our Clinical Biostatistics Services include :
Protocol Input – our input includes clinical study design, sample size calculations and consultancy advice during the start up of a study.
Randomization/Unblinding – we offer production of randomizations including production of emergency unblinding envelopes.
Statistical Analysis Plan (SAP) and Output Shells – we optimize the use of our Consultant Statisticians to ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial.
Output Production – using Max Neo standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.
PK/PD Analysis - modeling the relationship between exposure and response using nonliner models and non-linear mixed effect modeling.
Production of Statistical Report/Clinical Study Report – our statistical and medical writing teams collaborate to produce high quality reports.
Interim Analysis/Data Safety Monitoring Boards (DSMBs) – we offer unblinded statistical support and advice for Interim Analyses and DSMBs.
Site Management Services
Max Neo Clinical Research performs site management services to act as the liaison between the site, the sponsor and the conduct of the study. We do this by continuous communication with every study site, starting with the collection of regulatory documents and continuing throughout enrollment, follow-up and project completion.
Max Neo Clinical Research understands that site training is key to ensure proper study conduct, quality data collection and to keep our sponsors’ projects on top of the to-do list.
Our Project Managers and CRAs institute training programs for all site staff to ensuring compliance with local regulatory and ICH-GCP guidelines and adherence to the protocol as well as timely patient recruitment. We develop effective study protocol tools, newsletters and subject enrollment aids to reinforce site staff training.
Our proven comprehensive site support model involves placing a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-to-day study conduct activities. In addition, weekly teleconferences are scheduled with the site throughout the project that allows our staff to review study status, CRF and query completion and assist with protocol questions and any other study related activities to ensure the study proceeds in a timely manner. Max Neo Clinical Research ensures all study information is current, prioritized, and available to Sponsors for effective site management
Monitoring
Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to:
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients