Medical Affairs

 

 

1.      Department Introduction
The medical department of Proswell is a professional medical team with clinical background and experience in clinical trials, committed to providing clients with professional and high-quality medical services. We mainly offer medical services in four aspects: medical writing, medical monitoring, pharmacovigilance and medical consulting.
 
      Medical writing: Our medical writers with master's degree or above have rich experiences in the following therapeutic areas: tumor and adjuvant therapy, endocrine, rheumatoid immunology, hematology, gastrointestinal, cardiovascular, neurological system and gynecology. Types of medical documentations include: investigator’s brochure, clinical study review, study protocol, CRF, final study report and others related to clinical trials.
 
      Medical monitoring: Our medical monitoring team with master's degree or above has rich experiences in clinical practice and drug development design, who fully knows the primary objective and the key steps of clinical trial designing. From IND development and medical practice, we monitor the key points and difficulties in clinical trials to ensure the projects strictly follow their designs. Medical monitoring services are provided for the following areas: tumor and adjuvant therapy, endocrine, rheumatoid immunology, hematology, gastrointestinal, cardiovascular, neurological system and gynecology.
 
      Pharmacovigilance: Our PV team with master's degree or above has rich experiences in clinical practice and drug safety assessment. For clinical trials, we provide various support including strategy support for safety signal identification, adverse event reviewing, risk assessment and risk reduction, AE report of individual case and safety report writing, ensuring the safety of subjects, finding potential or major safety problems, and analyzing the impacts of safety issues.
 
      Medical consulting: The medical consulting team of Proswell offers consulting services for phase-clinical study of new products, including pharmacology and toxicology assessment, animal pharmacokinetics study evaluation, early stage clinical study evaluation, and human pharmacokinetics study, providing direction and strategy for subsequent clinical research, evaluating the enforceability in the process of clinical trials and expected post-marketing prospects, meanwhile analyzing the key points and possible difficulties encountered in subsequent study and providing consulting report for IND development.
2.      Our Team
Proswell has a powerful medical advisor team involving in several therapeutic areas such as tumor and adjuvant therapy, endocrine, rheumatoid immunology, hematology, gastrointestinal, cardiovascular, neurological and gynecology. Our advisors have rich experiences in clinical therapy and research in relevant areas who can provide authoritative and professional advice and guidance for clinical trials to ensure the scientificity, integrity, and safety on study designing, executing, analyzing and summarizing.
3.      Medical services
3.1 Medical Writing 
Proswell offers a comprehensive suite of medical writing services to support your clinical trial documentation needs from pre-market to post-market study. These relevant services can be offered as a full service or as a standalone module of a clinical trial, drug development program or medicalinformation service.
 
Whatever your medical writing demands are, Proswell delivers high-quality and timely services to ensure the progress of your project. Our medical writing experts ensure that your medical materials are clear, concise, scientifically accurate and fully compliant with relevant laws and regulations.
Our medical writing team with diverse therapeutic backgrounds can support your preparation of a wide range of medical materials, including:
      Clinical research overview of IND
      Investigator’s brochure
      Phase I-IV protocols   
      Informed consent form (ICF)
      Case report form (CRF) 
      Clinical study report (CSR)
      Individual case safety report (ICSR)
      Global clinical trial application
      Drug, device and biologic marketing application
      Medication guide and patient information leaflet (PIL)
      Premarketing and post-approval annual report
      Periodic safety report 
      U.S. Food and Drug Administration (FDA) briefing document
      Corrective action and prevention action (CAPA)
3.2 Medical Monitoring
The medical monitoring team of Proswell is committed to improve the quality of the global clinical trial and ensure the data fully reflecting the characteristics and nature of drugs, and assure the objectivity and scientificity of the clinical trial data.


We provide systematic and flexible medical monitoring services to support clients from early development of the new drug to its post-marketing study, including:
      Primary and secondary endpoint monitoring
      Monitoring and inspecting the consistency of each site
      Reviewing the medical logicality of case materials including original record and CRF
      Periodically collecting and analyzing the endpoints
      Bias factor analyzing
      Safety data monitoring
3.3 Pharmacovigilance 
Proswell’s pharmacovigilance team makes efforts to improve safety management of global clinical trials. In addition to helping to meet the escalating demands for safety services, we are working to advance pharmacovigilance technologies and processes to improve efficiency and to reduce cost. Most importantly, we help clients identify market value for the development of specific drugs and medical devices based on pharmacovigilance data.
Proswell’s pharmacovigilance group gives access to a professional and customized team serving for your needs and improving your monitoring standard. Our experienced group aids in evolving your safety monitoring and safety reporting practices in response to the changing regulatory standards, allowing you to evaluate and manage risk over your product.
We offer a comprehensive and flexible suite of pharmacovigilance and safety monitoring services from early development support to post-market initiatives, including:
      Safety signaling monitoring
      Individual case safety report (ICSR) and processing of serious adverse events (SAE)
      Periodic safety update report
      Medical device monitoring
      Support services for post-marketing product   
      Classification, assessment, and processing of ICSRs; as well as management of follow-up request
      Global regulatory reporting 
      Safety evaluation and medical review 
      Risk management strategy 
      Risk evaluation and mitigation strategy (REMS)
      Medical review of adverse event
      Safety evaluation and assessment
      Response to regulatory safety inquiry
      Escalate safety issue
      Review and sign-off safety document
      Benefit/risk assessment and communication
      Weekly and monthly AE report
3.4 Medical consulting:
The medical consulting team of Proswell offers services for phase-clinical research of new products, including pharmacology and toxicology assessment, animal pharmacokinetics study evaluation, early clinical study and human pharmacokinetics study, providing direction and strategy for subsequent clinical research, evaluating the enforceability in the process of clinical trials and the prospects of post-market products, meanwhile analyzing the possible key points and difficulties encountered in subsequent study and providing the consulting report for drug development.
      Pharmacology and toxicology assessment
      Pharmacokinetics study evaluation
      Clinical study evaluation
      IND development consulting service
      Safety consulting service
      Efficacy indicator consulting service
3.5 Feasibility Study 
A properly designed and executed feasibility study can provide a comprehensive assessment of a clinical trial’s specific challenges as well as strategies to mitigate risks before startup.
Proswell works directly with clients to design a feasibility study that is tailored to your clinical trial or program. During the design phase of the study, clients are designated with different project managers who are specialists in different areas. All of them have rich experiences in feasibility study and certain therapeutic areas. Project Manager will arrange and hold weekly telephone conferences to assess study findings and decide if it is necessity to make any modifications.
The project manager with expertise in conducting feasibility study and certain therapeutic areas is typically assigned to provide ongoing contact with clients. Weekly client teleconferences can be arranged and facilitated by the project manager to review the results of the study and determine if any modifications are required.
A properly conducted feasibility study can provide the following information regarding:
      Clinical trial concept interests the investigator
      Assessment in the current medical model
      Available patient population
      Possibility of patients agreeing to participate in the clinical trial 
      Potential modifications to clinical trial design and improvement in enrollment criteria
      Competing clinical trials
      Site capability assessment
      Research infrastructure
      Research personnel
      Regulatory requirements and timelines
      Review schedule of local institutional review boards/independent ethic committees
      Investigator’s requirement
      Projected patient enrollment rate
3.6 Medical communication
Proswell’s global medical communications team focused on global health care. We are passionate about improving patient health and providing high-quality medical information services to our clients through our multichannel contact centers. We build lasting partnerships with our clients and are thankful for their trust in Proswell as their medical communication provider.
Proswell provides comprehensive services that can be customized and integrated as a seamless full-service solution or a specific service to meet your specific need. Our experienced staff includingpharmacists, nurses, physicians, medical writers, epidemiologists and regulatory experts. We coordinate to ensure that you receive the highest level of service and solution, including:
      Medical information inquiry management
      Adverse event and product quality complaint management
      Marketing program support
      REMS support
      Medical information responses
      Product recall and crisis management
      Clinical trial support