Medical Writing Services
QRS provides effective commercial and academic scientific, medical and regulatory writing services. Our expert writers have clear understanding of the scientific, medical and regulatory concepts and ideas, and has been able to present the data and its interpretations in such a way that the target audience will understand and accept. We have a sound track record of data acceptance by regulatory agencies, notified bodies, academic institutes and other agencies.
We offer customized writing solutions in accordance to our client’s needs. Every project has a dedicated team specialized or having relevant experience in that area, which can get your project done right and on time, the first time!
Regulatory writing
- Regulatory compliant clinical study report (CSR)
- Interim reports
- CSR synopses for public disclosure
- Clinical study protocols
- Investigator Brochures (IB)
- Patient safety narratives clinical and nonclinical sections for the regulatory submissions
- Clinical evaluation reports for notified bodies
- Informed consent and patient brochures
- Periodic safety update reports (PSURs)
- Annual safety update reports (ASRs)
- Standard Operating Procedures (SOPs)
Publication support
- Original articles
- Meta analyses
- Literature searches
- Development and manage supplement publications
- Annotated publications
- Trial cards
- Systemic and other reviews
- Brief communications / reports
- Publication alerts
- CME slides
Medico-Marketing
- Flashcards
- Detail aids
- Newsletters
- Leave behind leaflets (LBLs)
- Brand lexicon
- Product monographs
- Booklets/compendiums
- Patient education materials
- Training documents
- Patient materials etc
Clinical Operations Services
Clinical research is a highly regulated industry. The success of the clinical trials depends on multiple factors; the most important being selection of the right vendors. The comprehensive list of activities along with standardized procedures and timelines are needed to formulate a robust study plan.
Clinical trial project management is an art, when executed well will lead to successful clinical trials and an increased sense of trust, collaboration and high performance long term business relationship. With our battery of high quality project management services we assure you that your project is in the right hands and you will have a competitive advantage over your competitors.
Pre-Study
- Scientific, medical and regulatory writing
- Site qualification or feasibility studies
- Study start-up activities (Regulatory & EC submission)
- Vendor management
- Budget negotiation
- Negotiation and execution of clinical trial agreement
- Management of investigator meetings
- Initial project team training
During Study
- Managing India operations of Phase II & III studies
- Recurrent project training
- Recruitment and retention strategies/plans
- Facilitation of site payments
- Safety monitoring and reporting
- Study monitoring
- Data management
- GCP compliance audit and reporting
Post Study
- Phase IV study
- Post Market Surveillance or Post Market Clinical Follow-up Studies)
- Statistical analysis with a regulatory compliant system in collaboration with our trusted and reliable partner
Quality Assurance Services
Quality is of paramount importance in the field of clinical research. It is one of the three pillars (other two being safety and efficacy) which holds the foundation of Ethical Clinical Research. Clinical research quality is designed and rooted in the clinical trial processes and we assure our clients that we are a system and process driven organization. Our quality system has been built on the Shewhart Model and we ensure that quality is inherent in every aspect of our processes and whatever we do.
Our quality assurance team has relevant training and experience on GxP regulated activities and quality assurance concepts. QAscent by its name means Quality in Ascent and is a true service provider in that regard. We provide QA services to pharmaceutical, medical devices, food companies, other institutions and companies in healthcare domain.
Our major strengths include, well documented procedures, flexibility, partnership, vast experience in multidisciplinary projects, transparent communications and deep knowledge of applicable regulations.
Quality assurance services:
QRS along with its partner organization has expertise, experience and capability in providing wide range of quality compliance services. Our list of collaborative services includes:
Trainings services:
- FOSTAC, QMS (ISO 9001), food management system (ISO 22000, FSSC, BRC, SQF, HACCP, AIB etc.), occupational health and quality management system (ISO 45000), environment management system (ISO 14000), energy management system (ISO 50001), good laboratory practices (ISO 17025), lab and allied trainings, internal auditor trainings (ISO 17025, ISO 22,000, FSSC 22000, HACCP, ISO 45000, ISO 50001, ISO 14001, BRC etc., and other corporate trainings (team building, goal setting, leadership, train the trainer, lean management, six sigma, five S, Kaizen techniques, TQM etc.
- Auditing services:
- Management system internal audits, second party audits, special mystery audits for hospitality clients, hygiene audits and GMP audits
- Testing services:
- Shelf life analysis, label claim analysis, nutritional analysis, residual analysis, microbial analysis, adulteration testing, migration study etc.
Quality assurance services for clinical trials:
- GCP quality system development
- GCP compliance and due diligence auditing including overall and study-specific compliance. Examples of types of audits include:
- Clinical investigator site audits
- Vendor and subcontractor qualification audits
- Internal operations compliance including process audits, process QC reviews, and departmental system audits
- Audits of key deliverables or study components, including study process documents, trial master files, reports, tables, and listings
- Software and computer system validationdocumentation reviews
- Independent database audits
- Client systems audits
- Pre-inspection audits
- Ethics Committee audits
- Development of Corrective and Preventive Actions (CAPA)
- Creation and review of standard operating procedures (SOPs), standard forms and templates, and study-specific procedural documents
- Training of Investigators and site staff on GCP and Indian Guidelines & Regulations
- Training of site Coordinators
Regulatory Affairs Services
QRS provides efficient and effective regulatory writing as well as regulatory consultancy services. Additionally, in case of end to end service, regulatory services are included in the package.We have an exceptional track record of data acceptance by regulatory bodies, notified bodies, academic institutions and other agencies.
You can rely on our knowledge and expertise with the Indian regulatory agencies through all phases of the drug-development. We offer customized project plans to meet different regulatory requirements. Our regulatory services encompass vide range of product categories like drugs, biologics including vaccines, medical device/IVDs, food and nutraceuticals, phytopharmaceuticals, cosmetics and herbal and Ayurveda products.
Our team always remain updated with the regulatory requirements to ensure that you get transparent advice through our proactive approach and that there are no surprises. Clients appreciate our meticulous communications keeping the stakeholders completely informed and engaged.
Regulatory services for clinical trial:
- Regulatory intelligence and strategy
- Local applicant support
- Clinical trial/investigation permission (global and local)
- Clinical performance evaluation
- Test license for importing small quantities of drugs, cosmetics, medical devices etc. for R&D, testing, and analysis purpose.
- Assist in Subject Expert Committee (SEC) meetings
- Registration on Clinical Trial Registry India (CTRI)
- Safety reporting to the regulatory agency
- Submission/notification of post approval changes e.g. protocol amendments, IB amendments, ICD amendments etc.
- Ethics Committee registration with CDSCO and DHR
Other regulatory services:
- Authorized agent registration holder support
- Investigational new drug, new drug, subsequent new drug, fixed dose combination approval
- Manufacturing license
- Import, registration and re-registration
- BA/BE studies approval and BE NOC for export
- Form 29 for Test Batch
- Whole sale license
- Free sale certificate
- Export NOC
- Regulatory support in terms of phytopharmaceuticals, Ayurveda drugs, Food import assistance, FSSAI compliance, licensing registration, product approval
Ethics Committee Services
Ethics Committee (EC) plays an important role in clinical research. We have been working closely with many ECs pan India and facilitating them from inception to registration with regulatory body.
There are various challenges an EC can face in their day today functioning hence we have created our services addressing each of these challenges. Be it EC constitution or liasioning with regulatory agencies or streamlining of the operations or training needs, we have tailor made solutions for all them.
EC constitution, formation & registration
- Support in identification and selection of EC member
- Liasioning with CDSCO for registration
- Liasioning with DHR for registration
- NABH accreditation consultancy
Management
- Standalone EC submissions to regulatory agencies
- Event reporting from EC to regulatory
- SOP modification
- Streamlining of the operations
- Process improvement
- Regulatory submissions
- Independent EC audit
- Ethics Committee Management Software (ECMS)
Training
- GCP Awareness
- Online & Offline
- Comprehensive or detailed training
Resources
- EC SOP Template
- Checklist for EC registration
- Training material
Technology Services
Technology is the way forward and we strongly believe in it. We have created tools to speedup your research process with quality in mind. Hassle free data collection in the study and Ethics Committee Management System (ECMS) software for smooth running of EC is the key area we are currently focused. With technology there are are endless possibility and our tech team is continuously in search of ways to incorporate tech in research hence we have more tech-for-research product in our pipeline.
Q-DATA is one of the most adaptive user friendly Electronic Data Capture (EDC) tools available. The system can be easily tailored as per the clinical study protocol requirements. With a steep learning curve Q-DATA boasts of being one of the robust, secure and reliable platform for recording, reporting and analyzing clinical trial data.
Features
Our feature loaded EDC system Q-DATA will help you in collection of quality data of your study. The robust design is complaint with regulatory requirements to keep your data safe. Few notable key features are:
Complaint
Our system is regulatory complaint and adheres to all the required guidelines for data collection tools. The USP of our system is being compliant but not complex.
Ease of use
The learning curve for the system is very small and any new user can self-train them self in no time. There are many tools available like, How-to guide, self-paced learning modules for each role.
Backup
We understand the value of data and that is why we have built a system which takes care of your data. Our system takes the back-up of data at regular intervals to minimize risk of data loss.
Security
Q-DATA has a robust design to cater to all size of clients. It is build to keep your data safe and for that we keep our system security up to date at all the times.
Flexibility
Q-DATA is designed in such a way that it has lots of flexibility to adapt and give optimum result. Study design, visits, examinations can easily be added or removed as per change in protocol design.
SARAL NITI is an Ethics Committee Management System (ECMS). It is designed around Ethics Committee’s daily functioning needs. EC has a very important role in a clinical study and SARAL NITI facilitates their smooth functioning. An intuitive yet robust and future ready software solution to equip ethics committees with online submissions, training & management; SARAL NITI is revolutionizing the ethics committee operations.
Features
Simplicity of SARAL NITI is what makes it the best in class easy to use ECMS currently available in the market. Though it is simple but has all necessary components to make it a one-stop-shop for all EC needs. Here is the list of major features of our system.
Online Submission
Investigators can upload all the required study documents as per the EC checklist and submit their study with one click.
Document Management
Documents can be categories and stored for easy and quick reference. CVs of the EC members, EC communications, SOP, Study reports etc.
Training
Now train all EC members and maintain their training records at one place. Keep track of completed and pending training of the members.
Finance Management
Keep track of the finance with ease. Pending EC fees, EC members payment, all EC related finance tracking at one place.
Reports & Notification
Create reports with different parameters as per the need, for example. All SAE reported, All the ongoing study enrollment, study specific reports etc.
Training Services
Robust training is vital to every aspect of an organization’s functions. Sound training improves employee performance, increases customer engagement, improves employee retention, and growth.
We specialize in providing specific training for clinical research professionals including ethics committee members, investigators, clinical research coordinators, and other stakeholders. We also train pharma leaders, managers, and medical representatives specifically equipping them for success in delivering the research data to doctors.
We train the food industry companies and clients for various ISO certifications and biomedical committees and ethics committees for NABH accreditation and regulatory compliance.
Clinical Trials
- Project team training
- GCP training for Investigator, site, monitor
- Therapeutic Area training
- Drug development
- EDC training
- Good Documentation Practice training for monitor & coordinator
- Essentials of consenting process
- Safety Reporting
- Clinical Trial Supplies – preparation, packaging, Labelling and shipment
Pharmaceutical
- Pharmaceutical Data Integrity
- CAPA
- Indian and Global Regulatory landscape
- for phamaceuticals
- Good Manufacturing Practices for Pharmaceuticals
- Pharmaceutical Medical Writing
- FDA Inspections Essentials
- GxP foundations and advanced
- Pharmaceutical Quality Management
- Writing effective Regulatory, Medical and Technical documents
Regulatory
- Current Indian regulations training for site and EC
- GCP training for EC members
- ECMS implementation training for EC
- Regulatory compliance for Medical Device industry
- SUGAM – Online filing
- Safety Reporting Timelines – Roles & Responsibilities
- Regulatory Documentation – Do’s & Don’ts
Food & Other
- FOSTAC
- QMS (ISO 9001)
- Food management system (ISO 22000, FSSC, BRC, SQF, HACCP, AIB etc.)
- Occupational health and quality management system (ISO 45000)
- Environment management system (ISO 14000)
- Energy management system (ISO 50001)
- Good laboratory practices (ISO 17025)
- Lab and allied trainings
- Internal auditor trainings (ISO 17025, ISO 22,000, FSSC 22000, HACCP, ISO 45000, ISO 50001, ISO 14001, BRC etc.
Across various industries, we provide corporate training for skill enhancement of the manpower. The training modules include that of team building, goal setting, leadership, train the trainer, lean management, six sigma, five S, Kaizen techniques, TQM etc.
Staffing Services
Besides being a full service CRO and providing end to end clinical trial solution we also provide standalone contractual staffing solution to support clinical research organizations, clinical trial investigators and sponsors to find temporary or contractual resource (clinical research coordinator, clinical trial associate, and clinical research associate) to meet their business objectives in the field of clinical research.
QRS network and experience in the field of clinical research helps us to find the right resource with the right skill sets, who can contribute to the success of your clinical research projects. Our staffing services are different from other service operators because we are a full service contract research organization and very well understand what is required to be a good clinical research coordinator, clinical trial associate and clinical research associate.
When you are in a need of clinical research coordinator or a freelance clinical trial associate you can rely on us for the best staffing services. We assure you that we will provide you the best talent in the market which matches with your requirements.
Investigator & Site Payments Services
Managing the investigator and site payment is one of the most challenging aspect of a clinical trial. This challenge becomes more complicated when a foreign sponsor wants to run a clinical trial in India, but does not have a registered legal entity of its own in India to execute contracts with sites/investigators and also to process investigator and site payments.
Here QRS specialized service for investigator and site payments provides extensive support to such sponsors by providing a legal entity who can formalize and execute contracts with the sites/investigators and also manage the investigator and site payments.
Investigator and Site Payment Process Includes:
- Preparation and finalization of clinical trial contract
- Negotiation of contract terms and budget with the Investigator
- Execution of the contract
- Setting up investigator payments system
- Based on the invoices raised by the investigators prepare invoices for the sponsor and request fund from sponsor for investigator/site payment
- On receipt of fund make timely payment to the investigators/sites
- Track investigator payments and provide timely updates to both investigators and sponsor
- Ensure 100% compliance with the statutory requirements