20 | ghp Executive Awards 2017 Best Pharmaceuticals Clinical Trials Director – India & Most Innovative Woman in Pharmacovigilance R&D Providentia Research GEX17012 Providentia Research helps the organizations: Develop and implement quality systems, quality policy, standard operating procedures, documentation processes. Pre-Audit inspections - work with CROs, clinical sites and pharmaceutical companies to facilitate and prepare them for audits and inspections. Third Party Audits – We provide third-party verification that proper SOPs are in place and consistently followed to ensure quality systems. Providentia Research offers a range of services including quality assurance across the Pharmacovigilance, Clinical, GLP and GMP sectors; medical writing and regulatory writing; as well as market research across the pharmaceuticals, healthcare and biotechnology spaces. The firm draws on the expertise and experience of Founder and Director Geeta, who has over 16 years’ global experience in the pharmaceutical industry, which includes work in Pharmacovigilance, Clinical trials (Phase I-IV, BA/ BE), New Chemical entity/ IND Directed studies, GLP and GMP. Her expertise includes conducting audits globally e.g., affiliates, service providers, contract research organization, business partners, clinical sites, data management in pharmacovigilance/ clinical area and also manufacturing locations, such as GMP /GDP audits for API and formulation. Providentia Research also provides independent monitoring services under her leadership through highly qualified and experienced monitors. The monitoring and auditing services are provided throughout the course of a study with a follow up of the corrective and preventive actions. She has also successfully established Global Pharmacovigilance Quality Assurance and Clinical Quality Assurance (Phase I-IV) group within companies. As part of her previous experience Geeta has led the quality assurance programme for the IND directed studies and clinical development of Synriam, an antimalarial in Asia and Africa – India’s first new drug which involved GLP/GCP and GMP audits. In addition, her work led her to facilitate due diligences /out-licensing and co-development of an NCE’s. She has led the teams for the implementation of GLP accreditation for Drug Safety Evaluation Units of pharmaceutical companies. She is also able to draw on a working knowledge of performing Audit of GxP IT systems (including the Qualification documents) with respect to CFR Part 11/ Annex 11 requirements of all Enterprise level Computer Systems. Alongside this, Geeta also has a strong knowledge of Medical Writing/Pharmacovigilance writing e.g. Investigator Brochure, Clinical trial protocols and Clinical Study Reports, Periodic safety update report (PSUR), Addendum to Clinical Overview (ADCO), CTD modules, safety narratives, Risk management plans, etc. in accordance with the international guidelines. She has an understanding and has authored market research reports in the Pharmaceutical, Biotechnology and Healthcare domain. Our mission is to collaborate with our clients to develop a mutually beneficial working relationship and provide effective support and help with the development of Quality Assurance programs and the required expertise to execute the same. I like to work in a collaborative manner with my colleagues and clients, understand the issues involved and facilitate the resolution of the same. I impress upon my colleagues that the success of our clients is our success and the reason for our existence and continuation in this profession. Listening and patience are two virtues which are of vital importance in my profession. We need to continuously learn and evolve so as to adapt to the rapid changes that are happening in the regulatory domain across the globe. Providentia Research is a dynamic and innovative consulting firm that provides services in auditing, medical writing and market research. We profile the firm and explore how Founder and Director Geeta Orga Bedi has helped to drive it to the success it enjoys today. Contact Details Company: Providentia Research Contact: Geeta Ogra Bedi Contact Email: [email protected] search.com The pharmaceutical market of Asia is currently estimated at more than $140 billion and is the third largest pharmaceutical market in the world after North America and Europe. Many Asian pharmaceutical companies from India, China and Japan are regarded as global players. Generic drugs hold a dominant share in the pharmaceutical market of Asia. However, Japan and Singapore have a strong base for patented drug market to treat both acute and chronic diseases. Big pharma companies are strengthening their base in Asia, particularly in India and China. It is estimated that China will become the second largest pharmaceuticals market in the world followed by India in the near future. Commensurate with the market growth, the number of clinical trials have also grown rapidly in the recent past. In order to become global players, Asian countries are progressively adopting higher quality requirements and strict regulatory regime. This trend brings an increased focus on pharmacovigilance, CQA, GCP and drug safety in this region. This vast knowledge is used to support her clients, as Geeta and her team at Providentia Research work hard to ensure that they remain at the forefront of emerging market developments and are able to provide their clients with the very highest level of support and service. This will remain the company’s ongoing focus as it seeks to build upon its current success, with various exciting developments, set to offer Providentia Research the opportunity to grow and support even more clients moving forward.