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A clinical Research organization (CRO) that provides support to pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.

Challenges and Preventive Measures in Literature Screening and Risk Management for Biosimilars Pepgra. Pharmacovigilance Services. Pharmacovigilance Services. How Regulatory Writing Plays an Essential Role in Clinical Research - Pepgra. Uses and Implementation Process of Electronic Data Capture (EDC) in Clinical Trial Monitoring Service Pepgra. FDA Device Approval Process Its challenges.

Clinical Research Organization Services | Contract Research Company - Pepgra

Difference stages of medical device development and drug development Pepgra. How to manage risks in clinical studies Top 5 tips Pepgra. 4 Labeling Challenges and Significance of E labelling in the Medical Device Industries Pepgra. Statistical Programming Services - Pepgra. Pepgra’s biostatisticians direct sponsors in trial design; conduct analysis and evaluation of clinical trials—on par with CDISC (SDTM and ADaM) standards.

Statistical Programming Services - Pepgra

Comprehensive clinical and regulatory biostatistics and statistical programming services in all phases of drug and device development. Pepgra offers regulatory biostatistics and statistical programming services as per International Conference on Harmonization (ICH) E9 guidelines. We have a thorough understanding of the science of diseases and compounds; this know-how equips us to provide comprehensive planning and assistance.

We offer advanced CRO biostatistical capabilities with solid experience in a wide range of therapeutics and complex study designs (e.g., adaptive, Bayesian BLRM statistics, especially for medical devices, outcome, depending on switching/crossover biomarker) and the implementation of complex methods in macros (RPFST, IPE, IPCW). Tips for a Medical Writer to Prepare a Successful NDA Pepgra. Regulatory Medical Writing Services in Clinical Research - Pepgra Healthcare. Pepgra offers global regulatory and clinical writing services.

Regulatory Medical Writing Services in Clinical Research - Pepgra Healthcare

The team delivers clinical study protocols and findings with precision. Reports are scientifically accurate, culturally sensitive, and meticulously compliant with regulations and statutory bodies. Top 10 Patient Recruitment Tips for Clinical Trials Pepgra. Pharmacovigilance Services. Side Effects of Drugs Products, Medical Devices & Drugs. Regulatory Writing Plays an Essential Role in Clinical Research. How Regulatory Writing Plays an Essential Role in Clinical Research Pepgra. Digital Transformation in Healthcare Healthcare Data Analytics Pepgra Healthacre. Guidance for Biomarkers into Early Phase Clinical Research Purposes - Pepgra Healthcare. Uses of Patient Registries for Clinical Studies to Acquire Unwavering Data.

In-Brief: The patient registry is a specific study or a detailed survey of research question or hypothesis generally.Clinical research statistical service is a collection of data from a particular population; the following details explain the patient registry and their methodological and operational aspects.Pepgra strengthens your knowledge about the patient registries in the medical field to develop future clinical aspects and studies in the clinical biostatistics and programming.

Uses of Patient Registries for Clinical Studies to Acquire Unwavering Data

Patient registry is a coordinated system takes place using observational methods to acquire unwavering data on patient population based on the specific disease, exposure and conditions. It follows the time. The patient disease registries are created by public organizations, including educational institutions, medical research association and clinical study design. Our biostatistics consulting services consider these essential factors to create and maintain a patient registry they are. References: Challenges And Solutions To Pharmacovigilance Literature Screening. Guidelines on Virtuous Pharmacovigilance Practices. In-Brief: Does the need for protection of patients and public health increasing?

Guidelines on Virtuous Pharmacovigilance Practices

Unquestionably yes. The science of regulating and understanding this process is known as pharmacovigilance for all clinical research organization.Medical-related problems for the Clinical trial Monitoring Services have a considerable impact on the pharmacovigilance process as it detects, monitors and analyze the medical activities says the world health organization(WHO).Pepgra explains the general guidelines that apply to the EU legislation to promote the regulations in health care sectors.

Introduction Pharmacovigilance system is an organization that fulfils all the legal process and regulations that are related to medicinal products and detecting its adverse effects. Quality cycle The quality system must be having the following activities a pharmaceutical regulatory consulting services should look after, Guidelines on Virtuous Pharmacovigilance Practices. ROLE OF BIOSTATISTICIAN AND BIOSTATISTICAL PROGRAMMING IN EPIDEMIOLOGICAL STUDIES – pepgra.

Health data contains important information that can help save lives and cro biostatistics services provide information to support public health initiatives.Biostatisticians and biostatistical programming services are highly sought after to make sense of the data available from studies on public health.


Epidemiology Epidemiology is a branch of medicine that deals with the study of disease in population, the incidence, distribution, and ways to control the same.Centres of disease control and prevention (CDC) explains epidemiology as a scientific and systematic data-driven study of the distribution and determinants of health-related states and events in specific populations and application of the same information for control of health problems. So, we see that epidemiology consists of three aspects: – Identification of disease patterns in a population,Identify causes or associated conditions andProvide data for prevention, control, and treatment of the health condition. Challenges and Opportunities in Software Driven Medical Sciences – pepgra. SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices.

Challenges and Opportunities in Software Driven Medical Sciences – pepgra

These softwares can be run on different operating systems and virtual platforms. Examples of SaMD include: standalone softwares running on general computers, smartphones and tablets.SaMD that can detect interrupted breathing during sleep by using a microphone of a smart device.SaMD that can analyze the heart beat rate. A software can behave as SaMD when it is run on a medical hardware device, but does not serve any intended purpose for the hardware.

However, if the software controls the hardware device or drives it, then it cannot be called SaMD. Softwares, when used as medical devices have several challenges, the major ones being clinical evaluation, scientific validity and clinical validation. The basic programming model of a SaMD is given below. Figure 1: SaMD Basic Programming Model Different softwares are used for medical purposes, and they include the following: Post-authorization stage of product cycle. – pepgra. What is Product cycle?

Post-authorization stage of product cycle. – pepgra

In pharmaceutical industry, product cycle consists of all processes from drug discovery to launch to access, which is closely monitored by regulatory bodies like European Medicines Agency (EMA) for European Union (EU) and Food and Drug Administration (FDA) for United States (US). The various stages include: – Discovery and development.Preclinical research.Clinical research with 3 phases.Regulatory body review.Post-authorization / Post-market monitoring. Scientific Literature Search Services. Screening published medical and scientific literature regarding medical devices, and medicinal products is a mandatory requirement for marketing authorization holder (MAH) or License holders.

Scientific Literature Search Services

MAHs need to regularly monitor the literature for suspected Adverse Drug Reactions (ADRs) and other information, including potential drug interaction, misuse, off-label use, and class effects. Pepgra offers pharmacovigilance Literature review search services as part of the drug safety and efficacy services. Our medical regulatory staff have extensive experience in searching for articles from multiple databases published and can comprehensively manage your literature screening requirement in a cost-effective manner in conjunction with writing periodic safety reports. Our literature specialist team of Pepgra has 15+ years of experience in global pharma, with a focus on literature. Our Comprehensive Literature Review Screening Solutions.

Challenges in the study design, conduct and analysis of randomized clinical trials – pepgra. In brief: The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings.Randomized clinical trials are deemed as a gold standard method for analyzing and evaluating the safety and effectiveness of medical devices or pharmaceutical drugs.The most challenging part of conducting a randomized clinical trial are related to handling ethical and regulatory systems.

Challenges in the study design, conduct and analysis of randomized clinical trials – pepgra

Clinical study trial is majorly comprising of four components which include study design, the conduct of the clinical trial, analysis of acquired data and reporting the results. In this article, we will discuss the details of the major components and the challenges that come at every stage and finally, the limitations and future prospects. The basic principle in conducting clinical research is that the data collection must be keenly monitored as it is the major source of information that will later be analyzed.

Reference: Challenges in the study design, conduct and analysis of randomized clinical trials – pepgra. Statistical Programming Services - Pepgra. Challenges in the study design, conduct and analysis of randomized clinical trials – pepgra. Clinical Research Organization Services. Regulatory Medical Writing Services, Global Regulatory Services, Medical Devices Writing Services. Clinical study design. Pepgra is your reliable CRO.

Clinical study design

Our experts in scientific, clinical, regulatory, and statistical study will design your clinical protocols and execute 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 with variation in the responses.

With a better-informed protocol, clinical trials can answer the objectives of the study while reducing the bias in estimating treatment effects thereby reducing the overall time, costs and also increase value to stakeholders. At Pepgra, we are sensitive to the need of balancing scientific, regulatory and logistical concerns to design and plan a successful clinical investigation. Clinical Trial Monitoring Services and Audit. Our highly trained clinical research associates (CRAs) ensure integrity of study and commitment to excellence—on par with the study protocols, clinical monitoring plan, standard operating procedures, and ICH-GCP standards. Clinical Research Organization, Regulatory, Scientific Writing Services. Pharmacovigilance Literature Search Services.

Pharmaceutical Legislation On Notice To Applicants And Regulatory Guidelines For Medicinal Products. Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use. – pepgra. Notice to Applicants The European Commission in tandem with proficient authorities from the Member States, the European Medicines Agency along with interested parties created the Notice to Applicants (NTA). This was done with the objective to fulfil the obligations of the commission with regards to article 6 of Regulation (EC) No. 726/2004, and with regards to the Annex I to Directive 2001/83/EC as per the amendments.

One of the first editions of the Notice to Applicants (which is volume 2 in the series “The Rules governing medicinal products within the European Union) was initially published in the year 1986. This notice was subject to further revisions following which a completed version was issued i.e., the second edition was published in 1989(European Commision, 2020).

Later, during 1993, the processes related to applications for marketing authorizations were modified and the mutual as well as centralized regulation procedures came into force from 1995. Volume 2 References. Risk managements documents required for the market placement of a medical device compared with a medicinal product – pepgra. In Brief The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.For medicinal products the risk management documents/plan is achieved byIf more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP) Introduction Risk is considered as an incident that might occur at any point of time, which might eject either it’s positive or negative affect on project.

Risk can occur due to many factors taken into consideration and one has to understand that not a single factor is responsible for any damage. The need for risk management documents/plans (RMP) RMP: What it involves. Relevant Medical Databases And Search Engines For Periodic Literature Screening – pepgra. Clinical Trial Design and Artificial Intelligence – pepgra. Clinical trials take up the last half of the 10 – 15 year, 1.5 – 2.0 billion USD, cycle of development just for introducing a new drug within a market. Therefore, any clinical trials services that end in failure tends to translate not just in losses in terms of investment for the clinical trial but also takes into its ambit the costs incurred as preclinical development costs.

This renders the loss for every failed clinical trial at 800 million to 1.5 billion USD(Harrer et al., 2019). Keeping these factors in mind, it would be beneficial to explore how Artificial Intelligence or AI as it is popularly known can be effectively utilized to re-mould the key phases of a clinical trial design with a view to augment the rate of success in the trial. Figure 1 pharma drug development cycle SourceHarrer et al.,(2019)

Medical Device Regulatory Consulting Services. Clinical Research Organization, Regulatory, Scientific Writing Services. Regulatory Medical Writing Services, Global Regulatory Services, Medical Devices Writing Services. Clinical Research Organization, Regulatory, Scientific Writing Services. Regulatory Medical Writing Services, Global Regulatory Services, Medical Devices Writing Services. Periodic safety update reports (PSURs) – pepgra. Introduction PSURs are pharmacovigilance documents that provide risk-benefit balance assessment.The notion of PSUR is to offer a wide and complex evaluation of risk-benefit balance of a medicinal product.PSUR reporting first came into existence in 1992.Purpose of PSUR is to provide an update of global safety experience with a specific pharmaceutical.It is imperative to consult the guideline on good pharmacovigilance practices (GVP) while preparing PSUR.MAHs are supposed to submit all PSURs in EU to the central PSUR repository.

PSUR; What is it? Periodic Safety Update Reports (PSURs) are nothing but pharmacovigilance Service documents that are intended to offer an assessment with regards to the risk-benefit balance of a specific medicinal product at time points that are predetermined, following its authorization. Challenges And Solutions To Pharmacovigilance Literature Screening – pepgra. 1.0 Background. Pharmacovigilance Literature Search Services. Regulatory Medical Writing Services, Global Regulatory Services, Medical Devices Writing Services. Medical Literature Monitoring and Entering Negative Reaction Reports – pepgra.

Preparing For The Future: The New European Union Medical Devices Regulation – pepgra. Clinical Research Organization, Regulatory, Scientific Writing Services. THE ROLE OF REFERENCING IN SCIENTIFIC WRITING - Nancy Edwin - Medium. Regulatory Medical Writing Services, Global Regulatory Services, Medical Devices Writing Services. Clinical Research Organization, Regulatory, Scientific Writing Services. Medical Device Classification In The European Union – pepgra. In Brief Different medical devices have different parameters through which it can be classified. With that reasoning, it does not make sense to subject all medical devices to stringent conformity assessments.Moreover, the onus of classifying a medical device is the responsibility of the medical device manufacturer.

The device manufacturer has to be aware about the class under which their device will fall under, right from the time the device is in the process of development. Scientific Writing Services. Media Monitoring.