Pre-study Documents


Pre-study Documents
Clinical trial application (CTA) is the pivotal document in drug/biological/medical device licensing. The CTA is submitted to the concerned regulatory authority where the manufacturer intends to market the product. In India, the CTA is submitted to the CDSCO. The application could be for Investigational New Drug, New Drugs Clinical Trial (for obtaining market authorization), Global Clinical Trial (clinical trial in various phases of development as a part of multinational clinical development). The application in Form 44 needs to be submitted along with the necessary documents and data.
The Clinical Trial Protocol is a document that describes the method to carry out a clinical trial. The clinical trial protocol should contain general information, background information, objective and purpose of the trial, trial design, selection and withdrawal of the subject, treatment of the subject, assessment of the efficacy, assessment of the safety, statistics, direct access to source data/document, quality control and quality assurance, ethics, data handling and record keeping, finance and insurance, publication policy, and supplements. At various phases of the clinical trial, the protocol is amended as per the requirement.
An Investigation Broacher (IB) is a document consisting of clinical and non-clinical data on the product under investigation on the human subjects. The purpose of the IB is to provide updated information on the rationale of the study, key features of the protocol, dose, dose frequency, method of administration, physicochemical property of the product, pharmacokinetics, etc., to clinical investigators and others involved in the study. Our in house medical writing team has years of experience in writing, reviewing and updating the IB. We write the IB as per the ICH guidelines and format.
Informed Consent Document is an indispensible part of clinical trial research. It is used in seeking the permission of the subject/patent, wherein the subject confirms his or her willingness to participate in the trial after being informed on every aspect of the trial. We prepare the document as per ICH guidelines and provide translation service on the document as per the native language of the patients/subjects participating in the study.

To ensure transparency in clinical research, increase awareness among the public about the ongoing clinical trial, and comply with stringent mandatory regulatory requirements, the European Federation of Pharmaceutical Industries and Association (EFPIA), the European Medicines Agency (EMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have made it clear that the sponsors of clinical trials have to publish the data in clinical trial registries like ClinicalTrials.gov. In India, the entry should be in the Clinical Trials Registry - India (CTRI, ctri.nic.in) database. Moreover, the clinical trial outcome should also be published in peer reviewed journals. These tasks seem to be Herculean for the sponsor company. However, Reseapropharma has a strong track record in medical writing and communication to support our clients in public disclosure and transparency of clinical trial data. We offer the following services.

  • Reporting the result of the clinical trial (EudraCT, ClinicalTrial.gov, PharmaCM)
  • Registration of Protocol Summaries (e.g. ClinicalTrials.gov, PharmaCM and rest of the global registries)
  • Layman Summaries (for patients who participate in the study)
  • Clinical Study Report Redaction for public disclosure


Post-study Documents


Pre-study Documents
The Clinical Study Report (CSR) is a comprehensive document consisting of the clinical and statistical description of the study conducted for a drug on human volunteers. All these data and the analysis reports are integrated in a single document including figures and tables in the main text of the report or at the end of the text with appendices for sample case report form, information pertaining to the test drugs/investigational product, investigator-related information, patient data listings, concerned publications, technical statistics data like computation, analysis, derivatives. This report should be clear, well organized, and easy to review. It should be submitted to the concerned regulatory authority within one year. We prepare the CSR as per the ICH E3 guideline.

Patient Safety Narrative (PSN) is written for all phases of a clinical trial, whether conducted on healthy volunteers or patients with disease or condition under investigation. PSN is written in case of Serious Adverse Eents (SAEs) and Adverse Events (AEs)leading to permanent discontinuation from the trial and in case of casualty. PSN is an indispensible component in clinical study reporting from the regulatory viewpoint. As per ICH E3, the PSN should include the following:

  • Nature, identity and outcome of the event
  • An indication of time relevant to study drug administration
  • The clinical course leading to the event
  • Relevant laboratory measures
  • Action taken with the study drug and timing with reference to the event
  • Treatment or intervention
  • Post-mortem findings (if applicable)
  • Investigator's or sponsor's opinion on casualty (if applicable)
Clinical overview (module 2.5 of CTD) includes the rationale of the particular product development, which includes current therapies for the particular disease and its unmet clinical need, claimed indication and dose, clinical development program, regulatory history, compliance with GCP. The next section of the document includes an overview of the biopharmaceuticals; it contains biopharmaceutical classification, formulation development, analytical methods, and biopharmaceutic study. The subsequent section of the document includes an overview of the clinical pharmacology, which contains pharmacokinetics and pharmacodynamics, drug-drug interaction, PK/PD relationship for safety and efficacy and clinical pharmacology conclusion. The other sections of the document include overviews of the efficacy, safety, benefits and risk conclusions. Finally, it contains the references. Our in-house team is experienced to write and review this document as per the regulatory requirement.
Module 2.7 includes clinical summaries, summary of biopharmaceutic studies and associated analytical methods, summary of clinical pharmacology studies, summary of clinical efficacy, and summary of clinical safety. This document describes in detail about the summary result of the individual study, the bio-equivalence study result, pharmacokinetic interaction study, bio-equivalence and dose proportionality, comparison and analysis of results across the study, comparison of efficacy results of all studies, comparison of results in sub-populations, analysis of clinical information relevant to dose recommendations, persistence of efficacy or tolerance effect. ISS contains clinical trial data of Phase-I study while ISE contains data of Phase-II, III and IV.
This section consists of a tabular listing of clinical studies and related information. For every study, this tabular listing includes information such as type of study, study identifier, location of study report, objective(s) of the study, study design and type of control, test product(s); dosage regimen; route of administration, number of subjects, healthy subjects or diagnosis of patients, duration of treatment, study status, and type of report.
The turning point in getting speedy approval and unhindered commercialization of a medicinal product or medical device during the initial stage of approval (or during the life cycle management) depends majorly on the quick and timely response to health authority queries. After submission of a market authorization application to the region-specific health authority, the health authority reviews the application and may revert with comments if there is any deficiency in the submitted document or data or if the data needs clarifications pertaining to the quality, safety and efficacy of the product. Our clinical and regulatory expert team is adept in responding to the Information Requests (IRs), Refuse to Review (RTR) or Request for Further Information (RFI) in an efficient manner to launch your product faster in the global market.
Completed dossier customization is a prerequisite for the Market Authorization Application (MAA) filing in the ROW market as per regional regulatory guidelines. At Reseapro, the experienced regulatory team is proficient in rendering this service to customers worldwide.


Product Label


Pre-study Documents
Labeling of the product in the pharmaceutical and medical device industry is a multifaceted process. The labels are prepared with great care to avoid errors and mistakes and minimize unwanted expenses of the manufacturer. Many pharmaceutical products are recalled because of errors in packing and labeling. The Market Authorization Holders (MAH) need to frequently update the Core Data Sheet (CDS) as and when there is a new safety, efficacy or warning update on the product. The package inserts and labels are generally filed along with the dossier for Market Authorization Application to the concerned regulatory authorities. Our expert global labeling team prepares and updates the label as per USPI and SmPC guidelines. The team also supports customers in preparing and updating the label as per ROW regulatory requirements.
Quality Control checks of the labels and all regulatory documents are done by our experienced team to ensure quality.


Medical Devices


Pre-study Documents
A clinical investigation plan is a document that includes the rationale, objective, proposed analysis, design, protocol, monitoring, and recordkeeping of the clinical investigation for a medical device. Our medical writers and clinical trial experts confidently execute the projects in accordance with all regulatory norms and guidelines.
Premarket notification 510 (K) is prepared and submitted to the FDA for the approval of a medical device. It is of three types, namely Traditional, Special, and Abbreviated. Under the New 510 (K) Paradigm, the Special and Abbreviated 510 (K) methods are developed. All Class II and III devices, along with certain Class I devices, under quality system regulation, need to be designed in compliance with 21 CFR 820.30. Premarket Approval (PMA) is the regulatory review process that evaluates the safety and efficacy of Class III medical devices. Keeping the sensitivity and risk involved in the Class III medical devices, a premarketing approval application is prepared as per Section 515 of the FD&C Act to get the market clearance. Our experts write, review, and apply the document to the concerned authority in a proactive way so as to achieve the authorization within the stipulated time.
Clinical Evaluation Report is a set of documents that is required to be submitted to the EU regulatory authority in order to market the medical devices of any class in the region. We have experience in Medical Device Directive (MDD) and Active Implantable Medical Device (AIMD) to write and review the Clinical Study Report (CSR) and Clinical Evaluation Report (CER) on behalf of our clients.
CE marking on a device implies that the product is complying with the essential requirements prescribed by the applicable directive and is passed through a rigorous conformity assessment procedure. This marking permits the product to be freely marketed in the European Economic Area (EEA). The product, which gets regulated by European health, safety, and environmental protection legislation, needs to carry this mark. We provide all necessary support in terms of documentation to our clients to obtain the marking on their products.


Miscellaneous


miscellaneous
A periodic safety update report (PSUR) is a post-authorization document intended to provide an evaluation of the benefits and risks involved in a medicinal product. In India, the PSUR needs to be submitted to the DCG (I) every six months for the first two years, and annually for the subsequent two years for any new drug as per Schedule Y of the Drugs and Cosmetics Rules, 1945. PSUR is also submitted to the region-specific regulatory authority. Our team has the expertise to write, review, and file the PSUR with regulatory authorities around the globe.
Patient Information Leaflet (PNL) is provided with the package inserts of certain medicinal and cosmetic products. It provides comprehensive information on the medicinal products for their safe and proper medication. A good PNL should be clear and easy to understand, and the patient or user of the product should be able to understand the content in a single reading. It is important to understand the tone, style, words, and amount of information keeping the target audience in mind. Our seasoned and versatile medical writers are adept enough in writing, reviewing and editing the PNLs.


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