Services offered by Good Society for Ethical Research
Consultancy Services
Clinical Research Project Management
BIO-STATISTICAL SERVICES
Team of GSER have a broad knowledge base in all aspects of clinical studies, from the initial stage of study planning, designing, calculating sample size requirements, to analysing, displaying and interpreting data in the interim and final stages of the study. In addition, our biostatistics team has board experience in preparing analysis for regulatory submissions in a manner that facilitates their review.
Our experts plan the analyses you’ll need before the study begins, then provide interim analysis, Final analysis reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses for DSMB and regulatory submissions.
Our biostatistics services include:
- Sample size calculation
- Hypothesis testing
- Randomization schedule
- Statistical Analysis Plan
- Efficacy analysis
- Safety analysis
- ANOVA
REGULATORY SERVICES
Team GSER consulting for questions regarding regulatory channels to help clients achieve the most efficient path to market the new drugs and biological products. Clients avoid frustrating and costly delays by relying on GSER experts for pre-submission quality reviews to ensure completeness, adequate strategic approach, scientific accuracy, and ease of agency review.
A well-designed regulatory submission meets the information needs of all relevant stakeholders. Team GSER can assist you in devising a strategy to collect the data that is needed to support your endpoints, while enabling you to meet both your business objectives and your obligation to the safety of study participants.
Our regulatory services includes:
- IND filing
- NDA filing,
- Registration of ethics committee
- CTRI registration
- Common Technical Documents
- SAE report drafting and submission
- Marketing Authorizations
- Constitution of DSMB
Pharmacovigilance Services
Team GSER offering Services along the PV Value chain right from Case Intake to Safety Risk Management. We will offers combination of offshore and onshore teams that can reliably serve the entire PV spectrum.
Safety is a key component of clinical trial. Pharmacovigilance services offered by GSER will help your team to create safety management plans to avoid unfortunate trial outcomes. Maintaining safety standards adds to trial integrity, patient safety and reputation of the project sponsor. Additionally, the safety standards followed by your company that determines the outlook of the regulatory authorities towards the project sponsor.
Clinical trial projects test drug variants to discover a solution to a problem. Every effort is taken care by the trial team to understand the safety concerns in the procedure in a clinical trial project.
Since every project has a different scope, we create a safety management plan by studying all ends of the project that we work on. Biosphere can efficiently deliver the safety reports at a faster pace so that necessary steps can be taken to tackle issues on time.
Our P.V. team includes Qualified Person Responsible for Pharmacovigilance as well as Drug Safety Physicians and PV Subject Matter Experts that provide unparalleled expertise to our clients in an end-to-end process – starting with the scoping design phase, during the pilot and throughout the outsourcing implementation.
Service Offered :
- Customised safety monitoring services
- Safety Adverse Events (SAE) management and reporting
NABH ACCREDITATION CONSULTANCY
National Accreditation Board for Hospitals and Healthcare Providers (NABH) is a constituent board of Quality Council of India (QCI), set up to establish and operate accreditation programme for healthcare organizations. NABH has been established with the objective of enhancing health system & promoting continuous quality improvement and patient safety. NABH provides accreditation to Ethics committee in a non-discriminatory manner regardless of their ownership, legal status, size and degree of independence.
Accreditation is an incentive to improve quality as well as capacity of registered Ethics Committee to confirm an ethical research on new drugs. Confidence in accreditation is obtained by a transparent system of monitoring over the accredited ethics committee and an assurance is given by the accreditation body that ethics committee constantly fulfils the accreditation criteria.
Applicant as an ethics committee and accreditation shall be granted to them as per details and scope provided in the application form available on NABH portal. GSER provides end to end consultancy for NABH accreditation, including training, Implementation support, leading to achievement of certification as per NABH accreditation and NABH certification Guidelines.
NABH ASSESSMENT PROCESS
NABH Assessment Process involves comprehensive review of Ethics Committee's compliance with NABH's standards. Cardinal principles of NABH assessment are;
- Ethics committee operations are based on sound principles of system based organization
- NABH standards are implemented and institutionalize into Ethics committee operations functioning.
- Safety of study participants as core values are established & owned by each EC members and staff during review and handling submitted clinical research protocol of all levels of Clinical Research.
- There is structured quality improvement programme based on continuous monitoring of EC review procedure and services.
Assessment Method
NABH has on its panel, qualified and trained assessors for objective evaluation of Ethics committee. The assessment team will include two or more healthcare professionals including a clinician, healthcare administrator, being rendered by the hospital. The NABH assessment process incorporates interviews with the EC Chairman, Member secretary, EC Members, and staff. It calls for on-site visits to EC office. Facility tours addressing issues related to physical assessment of infrastructure, equipment, security, etc. is integral elements of NABH assessment process.
Benefits for regulatory bodies:
Accreditation provides access to reliable and certified information on facilities, infrastructure and process followed in conducting clinical trials. It provides assurance and a sense of satisfaction to ethics committee/regulatory bodies that all the procedures and process of carrying out research are in accordance with laid principles as per New Drugs & Clinical Trial Rules 2019 (NDCT), Indian GCP and other applicable regulatory requirements as laid down by DCGI.
Benefits for Study participants:
Participants are the biggest beneficiary among all the stakeholders. Accreditation of ethics committee results in high quality of care and Participant’s safety. The participants are serviced by credential medical staff under the proper supervision of the Investigator duly following the protocols. Rights and welfare of the subjects are respected and protected including confidentiality of their identification.
Benefits for Sites/Ethics Committee:
Accreditation of an ethics committee stimulates continuous improvement. It enables sites in demonstrating commitment to quality care. It raises community and subject confidence in the clinical trials. It also provides assurance to other stakeholders that all the procedures carried out at the site(s) are complying to regulatory guidelines and standard.
Benefits of Accreditation
NABH accreditation provides a public recognition of the achievement of accreditation standards by a healthcare organisation, demonstrated through an independent external peer assessment of that organisation's level of performance in relation to the NABH standards.
Benefits for Site Staff:
The staff at the Sites/Ethics Committee is satisfied a lot as it provides continuous learning, good working environment, leadership and above all ownership of clinical trial processes by the ethics committee. It improves overall professional development of an Investigator, Ethics Committee members and staff.
About us
Good Society, is an independent body constituted of Medical and Non-Medical professionals, and incorporated under the Society Registration Act XXI of 1860.
