Developing an innovative medicine that can bring benefits to millions of people is a lengthy, cost-intensive and rigorous process. Typically, the research and development for a new drug spans over 10 or more years with almost 7 years dedicated to pre-clinical trials alone.
The R&D and patent process of a new drug begins with a company obtaining a 20 year patent for its new drug and almost 10 or more years of this 20 year period is dedicated to pre-clinical trials alone. On an average, this leaves only 9 years for a company to fully commercially leverage its innovation in the market before the entry of generic competitors. After the entry of generic competitors, it is widely observed that the sales figures plummet as the company no longer enjoys monopoly or exclusivity to sell the drug in the market. Therefore, it becomes crucial that at each and every stage of the drug – from its conceptualization to its entry in the market and its eventual period of exclusivity is optimized and efficiently managed including documents which churn out in huge numbers at each stage of the pre-clinical, clinical and commercialization stages. Any slip-up here can snowball and affect the time to market (TTM) of the product.
Document management in pre-clinical phase
Scientists spend a lot of years in finalizing the right combination of chemical and biological substances as they venture to make a new drug. This process culminates in Investigational New Drug (IND) application with the Food and Drug Administration (FDA). It is only after approvals from FDA are in place that further pre-clinical trials and product development is allowed.
In the discovery phase of a medicine, large volumes of documents are generated including laboratory and animal studies, biological and chemistry tests, manufacturing tests and pharmaceutical development studies. The process of IND submission mandates the consolidation and compilation of every information about the drug being developed – its composition, manufacturing of compounds, the effect on human body and / or animals, its chemical structure and any potential / observed side effects.
In order to efficiently handle the ever-increasing volumes of documents and also to comply with FDA regulations which stipulate document control requirements, management of IND documentation assumes critical significance in pharmaceutical firm.
Document management in clinical phase
It is quite fair to say that while pre-clinical phase is aimed towards IND submission and its relevant document compilation, it is the new drug application (NDA) – an equally important regulatory requirement that comes into significance in the clinical phase of a drug development. The clinical studies which span 10 years or longer on an average, churn out documents from sponsors, contract research organizations (CRO), study sites and enrolled patients.
The Trial Master File (TMF) is a collation of all these documents and details on the way the clinical study was carried out. The proof of safety and efficacy of a new medicine is established in the clinical study, after which all the data and supporting documents are submitted by a sponsor in a marketing application.
As in the previous phase, the current phase of drug development also requires an effective document management procedure to achieve desired levels of statutory compliance and efficiency in filing, storing, retrieving and presenting related documents. Since there are multiple submissions required at each stage for achieving the eventual approval for manufacturing and marketing the product, the importance of document management can’t be overemphasized.
Commercialization, product launch, and post-market phase of pharmaceutical document management
Upon receiving NDA approval from FDA, a company can start marketing and selling the new drug in the marketplace. But this doesn’t in any way limit the communications with the regulatory authority as the company has to recurrently submit amendments to regulatory agencies with information regarding manufacturing changes, adverse event reports, and annual reports etc.
The areas of quality control, manufacturing, marketing, and sales generate a lot of documents that need timely and periodic submissions to the regulatory authorities in the commercialization phase of the drugs. The documents generated belong to quality-related processes for handling corrective and preventive actions (CAPA), electronic batch records (EBR), consumer complaints, adverse event reports, quality audits, deviations, and nonconformance etc.
Therefore, all the 3 phases of a drug development requires a document management practice which helps a company to focus on its core activities and thus accelerate the time to market.
Benefits of an effective document management system in pharmaceutical firm
1. A central repository of documents from pre-clinical to post market stage makes search, retrieval and update of documents easy.
2. Improved information sharing with external bodies
3. Improved data quality due to automation
4. Enhanced information security by restricting unauthorized access
5. Enhanced and easy access to stored records and information assets
6. Workflow automation helps easy flow of information between internal and external stakeholders based on rule based routing to determine needed activity
7. Reduced redundancy and duplication of information
8. Regulatory compliance by creating audit trails of access and activity performed on stored information