Our- Experience


Our experiences in the field of clinical research are varied and encompass the different facets of the industry


Regulatory Affairs and the CE marking
for German Medical Device Manufacturing Firm.
Based on the requirements for medical devices to be marketed in the European Union, Biohealm has extended its services for a multinational corporation. Here, we set forth to gain the CE marking by using the MEDDEV 2.7.1 rev 4 guidelines as provided by the EMA. This also included regulatory writing that required for us to prepare the Clinical Evaluation Report (CER) based on regulatory requirements. Our services however, did not stop there and extended till the CE marking was achieved. Our team of expertise undertaken a robust methodology to collect (safety reports, results from published literature, PMCF studies, registries, and other data about device usage from Embase, Medline etc – gap analysis), appraise and analyse clinical data that demonstrated the scientific validity in terms of safety and performance and submitted the report in a timely manner.
Our expertise translated the regulatory guidelines meticulously by looking at various harmonized and international standards (such as EN ISO 14155:2011 (good clinical practice), EN ISO 14971:2012 medical devices – application of risk management to medical devices) and legislations.


Our support in post- marketing surveillance is holistic in nature. More recently we have enabled for the implementation of a fast post marketing surveillance based on GPSP for optimum data support of high quality.
For another client, we have conducted the examination of regular safety reports the re-examination of applications. We have also prepared the implementation guidelines and ensured the preparation of contracts with the study sites for the conduction of PMS. Besides this, we also aided in the management of research costs.
In terms of pharmacovigilance we have provided high quality services which has been appreciated by our clientele. Here, we ensured the input of highly confidential data with taking the right security precautions where we also did an initial assessment for clinical trials as well as post marketing studies.
Primary case study analysis and primary review of safety assessment literature along with the translation of services with the due guidelines for EMA and Med Watch were another one of our services we have thus far executed to clients.
Post-marketing surveillance
For Indian Medical Device Manufacturing Firm


Biostatistics – Analysis, Interpretation
and Report Writing Service for European Firm.
Biostatistics

This is again an area where we have vast experience and have gained several valuable insights through working in this industry for the last few years. We have offered our niche expertise largely (across all our clientele) in statistical consulting services. This has included design of the protocol with respect to the samples, size of the sample, blinding and randomisation procedures as well as possible outcomes numerically determined. We also helped client in term of data processing, converting data to a format, missing statistics, intention-to-treat and per-protocol population analysis was carried out. All analysis are in compliance with Good Clinical practice (GC) such as EN ISO 14155 or equivalent standard.


Dossier preparation for European firm

preparation of the Common Technical Document (CTD) per the guidelines in various geographical areas including the USA, UK and the EU at large. Module 1-5 has been extensively prepared in advanced eCTD formats as per the guidelines set forth by various regulatory bodies. We also have vast experience in preparing the preclinical and clinical reports for any drug and medical devices. Besides this, our services have also been extended to preparing dossiers for dosage forms for ASEAN countries (ACTD).
Clinical Study Report (CSR) for Germany Based Firm

We have also had extensive experience in preparing the Clinical Study Report as per different regulatory guidelines and also in the independent preparation of the Clinical Trial Protocol (CTP) along with the preparation for the management of the clinical trial in terms of patients, patient numbers, method of the trial as well as budgetary control.
Medical writing
We pride ourselves in not only being in the management aspects of clinical trials but also experts at medical writing in the field. Our works encompass all the aspects of clinical research in this regard.


SAP and SAR Report
SAP and SAR are our other experiences.
SAP and SAR Report

SAP and SAR are our other experiences. For all the clients we have thus far, a comprehensive SAP as per the necessary guidelines (EMA, CDSCO, FDA, MHRF, and TGA) has been prepared. We have offered our support in the advanced systems using the Bayesian approach with our niche knowledge and experience in the area. The SAR has been extensively prepared for the new investigation product keeping in mind the necessary factors such as the efficacy and safety outcomes, the protocol as well as the SAP.
We have also performed a coordination of inquires set from the regulatory bodies and prepared adequate reports to that effect. Along with this, we have also prepared several interim analyses through the statistical analysis centre.