WRITERS AND EDITORS
- Clinical Trial Audit and Monitoring Services
- Clinical Study Design
- Global Regulatory & Clinical Writing Services
- Clinical Biostatistics & Statistical Programming
- Clinical Trial Patient Recruitment
- Regulatory Affairs
- Clinical Data Management
- Post-Market Surveillance
- Clinical Technology & Process
Clinical Trial Audit and Monitoring Services
Our well-trained clinical research associates (CRAs) are highly trained professionals who ensure the integrity of the study and committed to excellence
Efficient monitoring of Clinical sites from Site Qualification to Report generation
Pepgra offers risk-based high-quality services in clinical trial monitoring, that ensures scientific excellence and data integrity across operational centres and regional hubs. Our in-house project management and operations team travel across the globe to support the project team, by leveraging local knowledge of the regulatory environment. Our clinical research associate team, who are aware of local laws, regulations and guidelines will work with you on-site as part of your team – they bring the commitment, passion and motivation to maximize the potential of everyone.
We offer a remote monitoring solution that can be delivered to our customers, which would reduce the frequency of on-site visits and enhance data quality. Our experts ensure that there is perfect coordination among clinical research associates, project managers, sponsors, and clinical trial sites.
Pepgra CRO rigorously scrutinizes its CMD services and projects in terms of the teams involved in them and resources used with the aim to ensure details of every project are strictly kept within its operational zone. By providing our clients with the most sophisticated services in CDM, we have transcended the conventional model. We continue to strive to take CMD services to even greater heights.
Comprehensive Clinical Trial Monitoring Solutions
Clinical Trial Audit and Monitoring Services
Pepgra, a leading contract research organization (CRO) brings together experts in scientific, clinical, regulatory, statistical – put them to work for you to design your protocol and execute the trials.
Clinical Study design and protocols that balance the interests of multiple stakeholders
To estimate the magnitude of treatment effect or difference in the treatment effect, there is a need for a good trial design approach that allows the treatment effect to be sorted out from person-to-person variability in response. With a better-informed protocol, clinical trials can able to answer the objectives of the study, while reducing the confounding and bias in estimating treatment effects thereby reduces the overall time, costs and richer evidence of value to stakeholders
At Pepgra CRO, we are sensitive to the need of balancing scientific, regulatory and logistical concerns to design and plan a successful clinical investigation. Our team has experience in developing study design for both new drugs and medical device despite the risk stratification (or class) of the device. Our experts develop study design based on strong scientific evidence, and our study design experts regularly advise on the necessity, implications, and practicality of clinical study design factors.
Clinical Study Design Solutions
Global Regulatory & Clinical Writing Services
The Global Regulatory Medical Writing Unit at Pepgra delivers Clinical Study Protocols and Study Reports that are Scientifically accurate, Culturally Sensitive, fully Compliant with current regulations (ICH GCP guidelines), in a timely and Confidential manner.
End-to-End Regulatory Writing Services for Drugs and Medical Device
Pepgra, a Clinical Research Organisation (CRO), understand the importance of regulatory Medical Writing in Clinical Research that is written in a clear and precise manner which is easily understood by EMA (EU), FDA (USA), HPFB (Canada), PMDA (Canada), TGA (Australia), MCC (South Africa), ASIAN (Hong Kong), GCC, CIS (Russia) and any other reviewers. It is risky to submit a poorly written protocol which leads to a huge loss of time and money. Further, delays and additional revisions can have significant cost implications. However, our qualified regulatory medical writing services help you in composing well-written regulatory documents and ensure that your dossier is reviewed, edited and proofread properly that helps you save time and money. Pepgra regulatory medical writers work closely with your statistical, medical regulatory and data management team to deliver the meticulously accurate document to the highest ethical and scientific industry standards.
Regulatory & Clinical research writing experts have the capabilities and skills to prepare regulatory submission documents required to seek approval for drugs (new drugs application / abbreviated New Drug Application – ANDA or), devices and nutraceuticals (for health claims). The regulatory Medical Writing Solutions we offer include regulatory compliance solutions in preparing essential documents for clinical trial submissions such as investigator brochures (IBs), protocols, dossier development including common technical documents (CTDs), eCTD modules, periodic safety update reports (PSURs), development safety update reports (DSURs), annual safety reports (ASRs),
clinical study reports (CSRs), documents related to pharmacovigilance like risk management plans (RMPs), periodic safety update reports (PSURs) and other associated documents.
Pepgra Extensive Regulatory Experiences
Our comprehensive solutions for Pharmaceutical Companies
Full Dossier Development
Pepgra CRO team has extensive knowledge of Pharmacokinetics, Pharmacodynamics, Pharmacogenomics who can facilitate trial life cycles by establishing efficient processes that reduce costs and deliver a rapid return on investment
For Medical Device
Premarket, CE-Mark Report, Clinical Data, Post-Market Studies
Pepgra has extensive experience in preparing following reports for Class, I (low risk), IIa, IIb, and III (high risk): For the Medical device, we are compliant with MEDDEV 2.7/1 Revision 4 guidelines to perform the clinical evaluation.
Pepgra Advantages to ensure the highest quality
Our regulatory medical writers hold vast experience in handling a wide range of therapeutic areas and all phases of development that are sound from both a scientific and regulatory perspective.
Clinical Biostatistics & Statistical Programming
Pepgra provides direction to sponsors in the design, conduct, analysis, and evaluation of clinical trials.
Extensive research, clinical and regulatory biostatistics services to meet your individual research needs
Pepgra offers regulatory biostatistical analysis as per the principles outlined in the International Conference on Harmonization (ICH) E9 guidelines. We bring a deep understanding of the science of disease and compounds, thereby provide comprehensive planning assistance
We offer you the benefits of the most sophisticated technology in biostatistics. Our regulatory statisticians with a comprehensive understanding of time-tested and latest statistical methods give you an accurate evaluation of scientific data. They design and conduct experiments, analyze the date and interpret the results in the way the results best meet the people’s requirements. Our regulatory biostatisticians and programming teamwork as an integral part of the assessment process, thereby it assures that the statistical principles outlined in the ICH E9 adhere when generating clinical Trial data that intended to be submitted to regulatory authorities. Adhering to these guidelines are mandatory if the product has European (USA and Japan as well) Wide marketing especially for centralized and mutual recognition submission.
Our research team is continuously engaged in studying following the latest research on innovative methodologies and analytical techniques and collaborate with the biostatisticians in incorporating the new findings into our day to day services. We collaborate the best hands in the field of Health and medicine in providing efficient and cost-effective analysis related to neuroimaging and cardiac and pulmonary diseases, and many other clinical disciplines.
Pepgra CRO is committed to engaging in collaborative work with scientists across the world to enhance innovation and knowledge in public health, medicine, and biology. When necessary we meet face to face with our clients in cases where the project involves intricate specifications. We customize our services to meet your requirements and thus add value to the time and money you invest with us.
Comprehensive Biostatistical Solutions
Clinical Trial Patient Recruitment
We Streamline your recruitment strategy.
Pepgra patient recruitment team facilitate the recruitment process based on your protocol, pre-screening conditions and inclusion/exclusion criteria. You only pay for the successful enrolment of patients thereby eliminate risk for sites and sponsors. Our team of experts dedicates their time and energy to recruit patients for all clinical trials. We have the capability to recruit patient population across the globe and any therapeutic area.
Comprehensive Patient Recruitment Solutions
Regulatory Affairs
Regulatory affairs are another core area for clinical trials. Pharmaceutical firms need a constant update on in-and-out on country-specific regulatory and ethics requirements to keep compliant with ever-changing legislation.
A team regulatory affair at Pepgra CRO advice on legal and scientific restraints from a global perspective thereby help you achieve your goals
Pepgra CRO offers its clients high quality Clinical and Regulatory Expert Services. Our expertise in the regulatory services draws extensively on the latest research for helping you design and implement clinical, regulatory framework depending on their requirement. Our services in regulatory services have been widely appreciated by our clients from pharmaceutical and biotechnology industries.
Our experts in regulatory affairs from world’s top pharmaceutical firms pay the closest attention to providing support in developing new medicinal products, integrating regulatory principles, and drafting and submitting relevant reports to health authorities. Our project management team will gather all documents including informed consent forms, writing the information for volunteers, competing the online IRAS form and also obtain necessary documentation and specialist opinion for ethics submission. We guide our clients in planning and implementing post-marketing activities. We provide enhanced guidance to the start-ups in discovering, testing, manufacturing, and marketing of medicinal products and thus ensure that the products supplied to make a useful contribution to public health.
We offer our clients customized service assistance in decision making, planning and management, and availing and executing strategic training and projects. Our experts keep a close track of the periodic and interim changes in the legislation in various regions and guide our clients in incorporating necessary changes in the products and advise them on legal and scientific restrictions and requirements. We deem it as our responsibility to employ the expertise of our legal advisors to negotiate with health authorities to obtain marketing authorization for medicinal products. Pepgra CRO understands the value of offering their clients access to international biopharmaceutical industry experts. One of the primary objectives of Pepgra CRO is to enable their clients to achieve their enterprise goals through increased product value and cost-effectiveness. We value the time our clients invest with us and the trust they have in our services. Therefore, we always push ourselves to deliver the best to them in all our services
Comprehensive Regulatory affairs Solutions
Clinical Data Management
In the market environment where there is continuous and increased monitoring on the part of regulatory authorities and considering the growth in the intricacy of clinical trial procedures, effective management of clinical data has emerged to be an aspect that is considered to be of an immense challenge to people concerned within clinical research
Considering these complexities and the basic nature of clinical trials, it essentially warrants the need for a system of clinical management that is state-of-the-art and extensive associated services that go a long way in simplifying the conduct, study design, compliance and management of discrepancy.
The process of gathering, storing and curating copious volumes of clinical data is deemed to be very intrinsic from the perspective of regulatory compliance. pepgra is a contract research organization that is engaged in full-service knowledge-based diverse activities and offers clinical data management solutions from Phase I through to post-marketing trials.
Pepgra offers clinical data management services that are specialized; clinical research organizations can stand to ensure that the quality of data is superior and also offers an assurance as to the integrity of the clinical data. Pepgra assures that the data that is being managed totally and absolutely complies with international standards with a view to ensure consistency within clinical data. In addition, our team also involves the use of data management best practices while adopting specific technologies that are latest to aid the process of clinical data management.
The process of gathering, storing and curating copious volumes of clinical data is deemed to be very intrinsic from the perspective of regulatory compliance. pepgra is a contract research organization that is engaged in full-service knowledge-based diverse activities and offers clinical data management solutions from Phase I through to post-marketing trials.
Pepgra offers clinical data management services that are specialized; clinical research organizations can stand to ensure that the quality of data is superior and also offers an assurance as to the integrity of the clinical data. Pepgra assures that the data that is being managed totally and absolutely complies with international standards with a view to ensure consistency within clinical data. In addition, our team also involves the use of data management best practices while adopting specific technologies that are latest to aid the process of clinical data management
Comprehensive clinical data management Solutions
Clinical Trial Audit and Monitoring Services
Pepgra has extensive experience in preparing PMS report. Our PMS experts adhere to the guidelines such as the European Medicines Agency (EMA), FDA, or other local country guidelines.
End-to-End post-market surveillance
In recent years, emphasis in legislation on post-market clinical data is becoming increasingly more prevalent. Thus, regulatory agencies have compelled the need for a feedback system specifically to provide early warning of quality problems and for input into corrective and preventive action processes for the manufacturers.
Pepgra CRO helps in advancing public health by detecting and assessing safety indications from available data sources using evidence-based techniques and recommends appropriate regulatory actions such as changes in labelling, Risk Evaluation and Mitigation Strategies and communication of relevant safety information. Pepgra CRO with its vast knowledge of pharma industry and impressive in-house capabilities offers their clients high quality and cost-effective services in post-marketing surveillance. Our post-marketing surveillance experts with strong educational background and experience in clinical training offer you effective solutions to mitigate adverse effects of drugs and medical devices. We leverage our state-of-the-art technological infrastructure to transfer the benefits of latest advancements in PMS to our clients.
We collaborate with expert PMS analysts and systems around the world to provide the best of PMS services to our clients. Our scrupulous adherence to global guidelines and best practices in documentation has enabled us to win distinct appreciation from our clients for consistency and professionalism. Our team has well-versed understanding of various guidelines including MEDDEV, and EN ISO. We understand the repercussions of administering drugs or medical devices that are likely to cause serious adverse effects in the patients.
Pepgra CRO organizational philosophy shows zero tolerance to even marginal fluctuations when it comes to maintenance of safety standards and effectiveness of the drug or medical device. Our service in the way of end-to-end complaint management system is very helpful to our clients in addressing issues related to patient outcomes in a cost-effective way. We ensure that all our PMS services conform to GPSP and GVP standards.
At Pepgra CRO, PMS experts undergo continuous scientific training to gain insights into the latest processes, procedures and technological advancements that impact the quality and delivery of PMS services. In addition, Pepgra CRO’s customized learning and development programs prepare our expert team to meet the challenges of technically complex PMS processes. Our team of consultants possess excellent knowledge of engineering, quality assurance, product engineering besides considerable regulatory compliance experience. We make the optimal use of global PMS template in offering PMS services to our clients. Our global network helps us offer to provide services of international standards at reasonable prices. Our blend of highly qualified and trained PMS specialists and sophisticated technological prowess is enabling us to provide effective PMS suggestions and recommendations to our clients.
Comprehensive Post-market surveillance
Clinical Technology & Process
Due to an enormous degree of technological innovation in the healthcare system, today’s hospitals have become technologically sophisticated centres of healthcare delivery and thus demand technologically competent staff
Pepgra CRO offers clinical technologists with the technology side of clinical operations where they play an important role in assisting the hospitals or physicians by providing the technological support they require.
Pepgra CRO offers you the state of the art services in clinical technology. Our long experience with Electronic Data Capture technology in clinical procedures has enabled us to become one of the frontrunners in clinical technology services industry. We serve biotechnology, medical device, and pharmaceutical companies with technological support to manage their clinical R & D trials, technology infrastructure, and business operations.
Our global delivery model provides native language support and multilingual support to serve your patients, investigators, site staff, and supervisors. We offer complete assistance in site assessment and internet service provider connectivity. We evaluate technological infrastructure of the site and ramp-up requirements that would facilitate access to clinical applications and facilities. With our in-house expertise, we ensure that your sites are equipped with custom software images. We provide the necessary hardware support besides solutions for breakage, warranty repairs, and sophisticated remote diagnosis devices to monitor the end-users in the trial.
Our close-out process has been so designed that the data delivered is highly secure and in time. Besides, the process has provision for quality assurance and confirmation from the investigators once they have received and reviewed it. Having understood the varying needs and preferences of our clients, we provide maximum flexibility and scalability to realize their enterprise goals. We leverage our in-house expertise in Life Sciences Support Service to provide the most cost-effective and high-quality service to our clients. Our assistance to pharmaceutical companies in upgrading their IT infrastructure has helped us understand the interaction between the pharmaceutical industry and IT in the global organization and upscale our service offering for Life Sciences Clients.
Our clinical technology training module, which is offered by our experts in-person or through the web, intends to develop your software skills and business process knowledge to help you obtain more accurate and comprehensive clinical trial data. We recognize the challenges before the sponsors and service providers. We are committed to establishing and developing sustainable contracts and working towards achieving a strong partnership with our clients.