Importance of Regulatory Services in Clinical Trials

With strict timelines and complex regulatory documentation process, conducting a clinical trial and running it fast is often easy in words than action. The key milestones, such as IRB approval, including drug shipment and patient randomization can be attained only after years of successful negotiation of clinical trial agreements and finishing important regulatory documents.

 

Most clinical trials get obstructed by the ineffective, labor-intensive processes from protracted contract negotiations to redundancy and the absence of a quality assurance, regulatory services and financial disclosure documentation.Time consuming and ineffective activation can hinder the investigator satisfaction and have a negative bottom-line influence for sponsors and CRO’s.


In the meanwhile the Sunshine Act has been increasing the significance of the financial disclosure in clinical trials. With a competent financial disclosure and regulatory policy strategy, sponsors cannot assure that the physical self-reported financial disclosure data are in line with the payment information that is being reported via the Sunshine Act. The discrepancy in information can maximize financial and regulatory risks. Hence, addressing the modern day complex compliance needs making use of manual processes tends to be error prone, time consuming and poses risk on a CRO. Automating and streamlining the business and financial management of clinical trials from contract and financial negotiations via payment management helps to position an organization to comply with compliance needs cost-efficiently.


Regulatory services and quality assurance offered by CRO’s in India comprise the vital components of the entire medical service portfolio. There is a separate team for regulatory and audit compliance that is in turn supported by an in-depth data on the regulatory processes and efficient liaison with multiple regulatory agencies that assures the effectiveness of the clinical trial approval process. Regulatory solutions provided by eminent CRO’s have helped in conducting audits of global and Indian regulatory agencies. Eminent CRO’s have been sanctioned for submission of studies to places such as NPCB Malaysia, MOH Israel, National Medicines & Poisons Board, Republic of Sudan and many more. The service portfolio includes the following:


* Formulation of regulatory strategies

* Compilation of the clinical trial application

* Submission and follow-up of the application

* Responding to regulatory agency queries

* Procurement of drug import licenses

* Procurement of NOC for export of biological samples

* Tracking of applications and approvals

* Safety Reporting

* Submission of Clinical Safety Report (CSR)

* Renewal of Import License


CRO’s offering regulatory services have their own legal network that assists in contract negotiations round the globe with clarity and efficiency, so that your legal team is well equipped to monitor risks on an enterprise level.


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