FAQ’S

Monitoring of clinical trials of Bio-equivalence studies is to oversee each and every activity taking place during execution of trials and it targets that the trial is conducted as per Protocol, GCP and SOP’s. it also helps ensure that trial subjects rights, safety & Wellbeing is maintained throughout the trial and that there is accurate reporting of trial results at its conclusion. 

Ans. Compliance to Good clinical practices together with following Good documentation practices is necessary and highly important in order to ensure right, safety and wellbeing of all the subjects recruited during the trials. System audit along with GCP audit also covers all documentation and SOP’s, safety measures, infrastructure, capabilities, resources to manage trials, training and experience and many other parameters checks during the audit.

Ans. No. GCP audit can also be conducted separately, however qualification audit covers all aspects of GCP as well. Pre-qualification audit of any vendor or CRO is always recommended as we are dealing and patients life and working under highly regulated environment.

Ans. In order to check and comply with international & regulatory standards for Good manufacturing practices. Pharmaceuticals are either producing Active ingredients or formulating and making medicines for Active ingredients for Human use, hence is necessary to have all Bonafede checks in place before getting into ordering any medicinal products or active ingredients.

Ans. Statistics helps to effectively manage and analyze the data gathered from Clinical Trials/Bio-equivalence studies. It is aimed to Ensuring efficient investigational designs and certifying consistency of results by controlling and reducing some types of bias. Statistical analysis is nothing but analysis and comparison of data sets generated after pharmacokinetic analysis. it allows to understand the scope and magnitude of the treatments’ impact on health, safety, and quality of life of patients.

Ans. Any medicinal product to be consumed or being consumed by human beings has to be safe, it must have been manufactured in quality, it must be efficacious enough to work for any particular indication and GXP compliance includes Good practices to be followed during manufacturing and testing of all medicinal products.

Ans. In order to nullify any scope of Bias during Research/Testing and Manufacturing of Medicinal/Pharmaceutical product.

Ans. Good Clinical Practices is a global standard to be followed for any pharmaceutical or nutraceuticals products to be tested in Humans. In all those Clinical trials or Bio-equivalence studies GCP compliance is necessary required to have assurance on protection of Right, Safety and Wellbeing of study participants. Any non-compliance to GCP is considered as Major observation by regulators and impacts on final product approval.

Ans. Any medicinal products whether a new molecule or a generic version of existing molecule has to pass through human trials before getting approval to market that product. And Human clinical trials are highly important to measure Safety and efficacy of any medicinal products before those are approved for safe use of humans.

Ans. Module 5 of the dossier covers Clinical study report along with other clinical data.

Ans. Yes. ICH guidelines cover all four aspects of entire pharmaceutical value chain. It has guidelines for Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M).

Ans. Pharmacokinetics has been defined as the quantitative analysis of the processes of drug absorption, distribution, and elimination. As such, it links drug dose to its concentration in biologic fluids and, for most drugs, determines the intensity and time course of drug action. A thorough understanding of pharmacokinetics is essential in building treatment plans involving medications. Pharmacokinetics, as a field, attempts to summarize the movement of drugs throughout the body and the actions of the body on the drug.

Ans.  International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use.

Ans. We at Anacon Research provide full Monitoring programme starting from site feasibility till close out visit for clinical trials for new chemical entity, 505b2/Hybrid application products and bioequivalence studies for Generic products. We also serve our customers for Pre-qualification audits or routine GCP compliance audits of a CRO.

Ans. Yes. We at Anacon Research perform GMP Audits and Qualification audits of pharmaceutical manufacturers on behalf of our customers all across the globe.

Ans. We at Anacon Research can help you facilitate your Audits for GCP/GMP and we can support for any statistical work needed including SAP preparation, PK and statistical analysis. Finally we can assist for any kind of consultancy work needed including In/Out Licensing of Pharmaceutical products, establishment of quality systems and set up of green field projects for CRO/Plant set up, Regulatory services etc…